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  • HP:0100526: Neoplasm of the lung
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    HP:0100526: Neoplasm of the lung

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (35)


    Name (Synonyms) Correlation
    drug1030 Control Wiki 0.32
    drug3462 SBRT Wiki 0.29
    drug642 Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulation Wiki 0.29
    Name (Synonyms) Correlation
    drug2770 PF-07104091 monotherapy Wiki 0.29
    drug2673 Olaparib Oral Tablet [Lynparza] Wiki 0.29
    drug286 Anatomic Pulmonary Resection Wiki 0.29
    drug4124 UCPVax + Nivolumab Wiki 0.29
    drug1305 EHR-based Clinician Jumpstart Wiki 0.29
    drug1442 Exercise booklet Wiki 0.29
    drug3871 TBD Compound 3 Wiki 0.29
    drug4688 questionnaire and optional interview Wiki 0.29
    drug4371 anti-CD40 antibody (CDX-1140) Wiki 0.29
    drug1490 FLT3 Ligand (CDX-301) Wiki 0.29
    drug4448 ctDNA blood sampling Wiki 0.29
    drug3870 TBD Compound 2 Wiki 0.29
    drug4133 Ultra Brief Online Mindfulness-based Intervention Wiki 0.29
    drug3780 Stereotactic Radiotherapy Wiki 0.29
    drug2768 PF-07104091 + palbociclib Wiki 0.29
    drug3735 Standard of Care Treatment Wiki 0.29
    drug1887 IgG test Wiki 0.29
    drug3869 TBD Compound 1 Wiki 0.29
    drug4745 standard chemotherapy Wiki 0.29
    drug2769 PF-07104091 + palbociclib + letrozole Wiki 0.29
    drug164 AZD1390 Wiki 0.29
    drug2214 Lung Cancer Screening Decision Tool Wiki 0.29
    drug1118 CytoSorb 300 mL device Wiki 0.29
    drug1035 Control Intervention Wiki 0.29
    drug3258 Radiotherapy Wiki 0.20
    drug2251 MSC Wiki 0.20
    drug3090 Probiotic Wiki 0.17
    drug1620 Gam-COVID-Vac Wiki 0.14
    drug832 Camostat Mesilate Wiki 0.10
    drug4249 Vitamin C Wiki 0.08
    drug4650 placebo Wiki 0.07
    drug2916 Placebo Wiki 0.01

    Correlated MeSH Terms (27)


    Name (Synonyms) Correlation
    D008175 Lung Neoplasms NIH 1.00
    D002289 Carcinoma, Non-Small-Cell Lung NIH 0.52
    D046152 Gastrointestinal Stromal Tumors NIH 0.29
    Name (Synonyms) Correlation
    D001661 Biliary Tract Neoplasms NIH 0.29
    D001749 Urinary Bladder Neoplasms NIH 0.29
    D055752 Small Cell Lung Carcinoma NIH 0.20
    D008545 Melanoma NIH 0.17
    D010051 Ovarian Neoplasms NIH 0.17
    D016491 Peripheral Vascular Diseases NIH 0.17
    D058729 Peripheral Arterial Disease NIH 0.14
    D014652 Vascular Diseases NIH 0.14
    D008103 Liver Cirrhosis, NIH 0.14
    D009369 Neoplasms, NIH 0.14
    D064726 Triple Negative Breast Neoplasms NIH 0.13
    D015179 Colorectal Neoplasms NIH 0.13
    D009362 Neoplasm Metastasis NIH 0.13
    D051437 Renal Insufficiency, NIH 0.12
    D007676 Kidney Failure, Chronic NIH 0.11
    D006333 Heart Failure NIH 0.08
    D017563 Lung Diseases, Interstitial NIH 0.08
    D002908 Chronic Disease NIH 0.08
    D029424 Pulmonary Disease, Chronic Obstructive NIH 0.07
    D008171 Lung Diseases, NIH 0.06
    D003141 Communicable Diseases NIH 0.02
    D007239 Infection NIH 0.01
    D045169 Severe Acute Respiratory Syndrome NIH 0.01
    D018352 Coronavirus Infections NIH 0.01

    Correlated HPO Terms (16)


    Name (Synonyms) Correlation
    HP:0030358 Non-small cell lung carcinoma HPO 0.52
    HP:0100574 Biliary tract neoplasm HPO 0.29
    HP:0009725 Bladder neoplasm HPO 0.29
    Name (Synonyms) Correlation
    HP:0100723 Gastrointestinal stroma tumor HPO 0.29
    HP:0030357 Small cell lung carcinoma HPO 0.20
    HP:0100615 Ovarian neoplasm HPO 0.17
    HP:0012056 Cutaneous melanoma HPO 0.17
    HP:0001395 Hepatic fibrosis HPO 0.14
    HP:0002664 Neoplasm HPO 0.14
    HP:0100834 Neoplasm of the large intestine HPO 0.13
    HP:0000083 Renal insufficiency HPO 0.12
    HP:0004950 Peripheral arterial stenosis HPO 0.11
    HP:0001635 Congestive heart failure HPO 0.08
    HP:0006515 Interstitial pneumonitis HPO 0.08
    HP:0006510 Chronic pulmonary obstruction HPO 0.07
    HP:0002088 Abnormal lung morphology HPO 0.06

    Clinical Trials

    Navigate: Correlations   HPO

    There are 12 clinical trials


    1 Incorporating Veterans Preferences Into Lung Cancer Screening Decisions

    Veterans have a high risk of developing lung in comparison to general populations due to their older age and smoking history. Recent evidence indicates that lung cancer screening with low dose CT scan reduces lung cancer mortality among older heavy smokers. However, the rates of false positive findings are high, requiring further testing and evaluation. Preliminary studies report that while some Veterans are enthusiastic about screening, others are highly reluctant. Patient preferences should be considered as part of an informed decision making process for this emerging paradigm of lung cancer control. Effective methods for preference assessment among Veterans have not yet been developed, evaluated, and integrated into clinical practice. The specific aims of this study are to 1) elicit patient and provider stakeholder input to inform the development of a lung cancer screening decision tool, 2) develop a web based Lung Cancer Screening Decision Tool (LCSDecTool) that incorporates patient and provider input, and 3) evaluate the impact of the LCSDecTool compared to usual care on the decision process, clinical outcomes, and quality of life. (5/8/18)-This project involves the recruitment of both Veterans as well as health care providers/leaders. Patient recruitment efforts at both sites will target male and female patients enrolled in a Patient Aligned Care Teams (PACT) who are eligible for lung cancer screening. Our recruitment goals for patients are 40% African American, 5% Hispanic patients, and 10% women. (10/25/2018) Patient recruitment efforts at both sites will target male and female To Date, 32 Veterans have signed the consent form and completed their portion of the trial (16 at CMCVAMC and 16 at West Haven, CT). To Date, 61 Providers have completed their portion of the trial (18 at CMCVAMC and 43 at West Haven, CT). Enrollment for Phase 1 is complete. Enrollment for Phase 2 will begin in June, 2018.patients enrolled in a Patient Aligned Care Teams (PACT) who are eligible for lung cancer screening. Our recruitment goals for patients are 40% African American, 5% Hispanic patients, and 10% women. To Date, 9 Veterans have signed the consent form and completed their portion of the trial (9 at CMCVAMC and 0 at West Haven, CT). Enrollment for Phase 2 is ongoing with the intent to complete By November 30, 2018. (01/15/2019) Phase 2 patient recruitment is complete. 18 Veterans have signed the consent form and completed their portion of the trial (12 at CMCVAMC and 6 at West Haven, CT). 14 Providers have completed their portion of the trial (8 at CMCVAMC and 6 at West Haven, CT). Enrollment for Phase 3 will begin in February, 2019. To Date (7/1/2019) Enrollment for Phase 3 is ongoing with the intent to complete by February 28, 2020. To Date, 18 Veterans have signed the consent form and completed their baseline portion of the trial (18 at CMCVAMC and 0 at West Haven, CT). To Date (12/3/2019) Enrollment for Phase 3 is ongoing with the intent to complete by February 28, 2021. A 1-year study extension has been submitted and awaiting approval. To Date, 70 Veterans have signed the consent form and completed their baseline portion of the trial (65 at CMCVAMC and 5 at West Haven, CT). To Date (9/9/2020) Enrollment for Phase 3 has just resumed after being placed on administrative hold since March 2020 due to Covid-19. Secondary Site in West Haven, CT has been replaced by Milwaukee, WI. To Date, 90 Veterans have signed the consent form and completed their baseline portion of the trial (83 at CMCVAMC, 5 at West Haven, CT and 2 at Milwaukee, WI).

    NCT02899754
    Conditions
    1. Lung Cancer Screening
    Interventions
    1. Behavioral: Lung Cancer Screening Decision Tool
    2. Behavioral: Control Intervention
    MeSH:Lung Neoplasms
    HPO:Neoplasm of the lung

    Primary Outcomes

    Description: Decision regret as measured by a 5-item Decision Regret scale that is patient reported.

    Measure: Decision Regret

    Time: 1 month following intervention

    Description: Decisional conflict as measured by a 16 item Decisional Conflict scale that is patient reported

    Measure: Decisional Conflict

    Time: 1 month following the intervention

    Secondary Outcomes

    Description: State anxiety as measured by the State Trait Anxiety Index

    Measure: Anxiety

    Time: 1 month following intervention

    Description: Lung cancer worry as measured by a 7 item scale that is patient reported

    Measure: Lung cancer worry

    Time: 1 month after the intervention

    Description: Assessed by chart review

    Measure: Lung cancer screening uptake

    Time: 6 months after the intervention
    2 CSP #2005 - Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy Trial (VALOR)

    Patients with stage I non-small cell lung cancer have been historically treated with surgery whenever they are fit for an operation. However, an alternative treatment known as stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors believe both are good treatments and are therefore conducting this study to determine if one may be possibly better than the other.

    NCT02984761
    Conditions
    1. Lung Neoplasm
    Interventions
    1. Radiation: Stereotactic Radiotherapy
    2. Procedure: Anatomic Pulmonary Resection
    MeSH:Neoplasms Lung Neoplasms
    HPO:Neoplasm Neoplasm of the lung

    Primary Outcomes

    Description: Survival estimates will include death from any cause.

    Measure: Overall Survival

    Time: From date of randomization through study completion, up to 10 years

    Secondary Outcomes

    Description: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and Lung Cancer (LC 13) survey instruments will assess patients' general state of physical, social/family, emotional and functional well-being.

    Measure: Patient reported health-related quality of life

    Time: 5 years

    Description: The St George's Respiratory Questionnaire will evaluate respiratory symptoms, activity limitations from breathlessness, and impact of respiratory function on social and psychological functioning.

    Measure: Respiratory Symptoms

    Time: 5 years

    Description: The EQ-5D-5L (EuroQOL-5D) survey will measure quality adjusted life years.

    Measure: Health State Utilities

    Time: 5 years

    Description: Cause of death will be determined by an independent adjudication committee.

    Measure: Lung cancer mortality

    Time: From date of randomization until date of death from any cause, assessed up to 10 years.

    Description: Post-treatment surveillance imaging will evaluate patients every 6 months for local, regional, and/or distant disease control.

    Measure: Tumor patterns of failure

    Time: 5 years

    Description: The Forced Expiratory Volume at 1 second (FEV1) will evaluate an objective measure of breathing function.

    Measure: Respiratory Function

    Time: 5 years
    3 Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung : a Randomized Non Comparative Phase II Trial

    Lung cancer is the most commonly diagnosed malignancy and the leading cause of cancer-related mortality both in men and women worldwide. The past few years have demonstrated great progress in the field of tumor immunotherapy through agents that address mechanisms of immune escape notably, so called immune checkpoint inhibitors (ICB). Indeed, ICB have emerged as a fatal weapon in the anticancer treatment arsenal. Anti-PD-1 and anti-PD-L1 antibodies have shown promising results in several cancers including Non-small Cell Lung Cancer (NSCLC) patients. Although such ICB extend patient's survival compared with conventional systemic therapies, they fail to control cancer progression in a significant proportion of patients which can reach up to 50-60% in NSCLC. Recent literature highlights a range of factors involved in the heterogeneous responses and failures to ICB therapies. The challenge is how can ICB treatment efficacy be extended to majority patients? To respond to this question, to increase the success of immunotherapy, immuno-oncology community develops combinations approaches. The aim of these project is to evaluate the efficacy of Nivolumab plus a novel CD4Th1 inducer anti-cancer vaccine in NSCLC patients. Nivolumab (NIVO), which is an anti-PD-1 antibody, has shown promising results in 2nd line treatment for advanced NSCLC. UCPVax is a therapeutic anti-cancer vaccine based on the telomerase-derived helper peptides designed to induce strong TH1 CD4 T cell responses in cancer patients (NCT02818426).

    NCT04263051
    Conditions
    1. Advanced Non-small Cell Lung Cancer
    Interventions
    1. Drug: UCPVax + Nivolumab
    2. Drug: standard chemotherapy
    MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
    HPO:Neoplasm of the lung Non-small cell lung carcinoma

    Primary Outcomes

    Description: PFS is defined by the duration from the date of initiation of the treatment to the disease progression (RECIST) or death from any cause whichever occurs first, censoring cases without progression at the date of last disease assessment.

    Measure: 6 months Progression-Free Survival (PFS) rate

    Time: 6 months after the date of initiation of treatment (1st day of 1st cycle of chemotherapy)
    4 Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication for Older Patients With Serious Illness

    The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study will examine the effect of the EHR-based intervention to improve quality of palliative care for patients over the age of 65 with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are: 1) to evaluate the effectiveness of a novel EHR-based (electronic health record) clinician Jumpstart guide, compared with usual care, for improving the quality of care; the primary outcome is documentation of a goals-of-care discussion during the hospitalization. Secondary outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 30-day hospital readmissions; and 2) to conduct a mixed-methods evaluation of the implementation of the Jumpstart intervention, guided by the RE-AIM and CFIR frameworks for implementation science, incorporating quantitative assessments of effectiveness, implementation and maintenance and qualitative assessments of clinician perspectives on barriers and facilitators to future implementation and dissemination.

    NCT04281784
    Conditions
    1. Dementia
    2. Chronic Disease
    3. Neoplasm Metastasis
    4. Lung Neoplasm
    5. Pulmonary Disease, Chronic Obstructive
    6. Heart Failure,Congestive
    7. Liver Cirrhosis
    8. Kidney Failure, Chronic
    9. Lung Diseases, Interstitial
    10. Peripheral Vascular Disease
    11. Diabetes With End Organ Injury
    12. Palliative Care, Patient Care
    13. Health Care Quality, Access, and Evaluation
    14. Patient Care
    15. Inpatients
    16. Health Communication
    17. Patient Care Planning
    Interventions
    1. Behavioral: EHR-based Clinician Jumpstart
    MeSH:Neoplasms Neoplasm Metastasis Lung Neoplasms Liver Cirrhosis Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Interstitial Renal Insufficiency Kidney Failure, Chronic Heart Failure Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Chronic Disease
    HPO:Abnormal left ventricular function Abnormal lung morphology Chronic pulmonary obstruction Cirrhosis Congestive heart failure Hepatic fibrosis Interstitial pneumonitis Interstitial pulmonary abnormality Neoplasm Neoplasm of the lung Peripheral arterial stenosis Renal insufficiency Right ventricular failure

    Primary Outcomes

    Description: The primary outcome is the proportion of patients who have a goals-of-care (GOC) discussion that has been documented in the EHR in the period between randomization and 30 days following randomization The proportion is the number of patients with GOC documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our NLP/ML methods. Study staff will manually review and compare findings using a randomly-selected sample of charts using our standard EHR abstraction methods; manual chart abstraction will be the gold standard.

    Measure: EHR documentation of Goals of Care discussions

    Time: Assessed for the period between randomization and 30 days following randomization

    Secondary Outcomes

    Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR using our automated and validated methods.

    Measure: Intensity of care/ICU use: ICU admissions

    Time: Assessed for the period between randomization and 30 days following randomization

    Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the ICU during their (index) hospital stay will be collected from the EHR using our automated and validated methods.

    Measure: Intensity of care/ICU use: ICU length of stay

    Time: Assessed for the period between randomization and 30 days following randomization

    Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the hospital during that (index) hospital stay will be collected from the EHR using our automated and validated methods.

    Measure: Intensity of care/Hospital use: Hospital length of stay

    Time: Assessed for the period between randomization and 30 days following randomization

    Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of hospital readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.

    Measure: Intensity of care: Hospital Readmissions 30 days

    Time: Assessed for the period between randomization and 30 days following randomization

    Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.

    Measure: Intensity of care: ICU Readmissions 30 days

    Time: Assessed for the period between randomization and 30 days following randomization

    Description: Costs for intervention vs. control will be reported in US dollars and identified from UW Medicine administrative financial databases. Costs will be reported for total hospital costs and disaggregated costs (direct-variable, direct fixed, indirect costs). Direct-variable costs will include supply and drug costs. Direct-fixed costs will include labor, clinical department administration, and overhead fees. Indirect costs represent services provided by cost centers not directly linked to patient care such as information technology and environmental services. Costs for ED (emergency department) days and ICU days will be similarly assessed.

    Measure: Intensity of care: Healthcare costs

    Time: 1 and 3 months after randomization

    Description: From Washington State death certificates.

    Measure: All-cause mortality at 1 year (safety outcome)

    Time: 1 year after randomization

    Other Outcomes

    Description: Qualitative interviews after individual participation. Interviews will be guided by the RE-AIM and Consolidated Framework for Implementation Research (CFIR) to explore the factors associated with implementation (e.g., reach, maintenance, feasibility, inner and outer settings, individuals, and processes of care.) Individual constructs within these domains were chosen to fit this specific intervention and context.

    Measure: Key Implementation Factors

    Time: 3 months after randomization
    5 Observational Retrospective Register of Spanish Lung and Melanoma Cancer Patients With COVID19 Disease

    This is a multi-centre study on lung cancer patients which experienced COVID-19. Information on clinical features, clinical course, management and outcomes will be collected for both, thoracic cancers and COVID-19 infection. Firstly, investigators will be registered in an online secure registry. After that, a protocol will be developed in order to collect clinical data for the research. It will also include I on the care organization or the perception of the patient and their family members. The final stage will consist on retrospective data collection from patients. So, it is a retrospective study data collection, preceded by prospective data registry.

    NCT04344002
    Conditions
    1. Covid-19
    2. Lung Cancer
    MeSH:Lung Neoplasms Melanoma
    HPO:Cutaneous melanoma Melanoma Neoplasm of the lung

    Primary Outcomes

    Description: Describe characteristics and evolution of Spanish patients preferably with lung cancer who contract COVID 19 infection with identification and study of factors of interest, as well as clinical data.

    Measure: Clinical data of lung cancer patients with COVID-19 diagnoses

    Time: From the diagnosis of the COVID until the patient is cured or dies, whichever comes first, assessed up to 5 years

    Description: Describe characteristics and evolution of Spanish patients preferably with lung cancer who contract COVID 19 infection with identification and study of factors of interest, as well as data about diagnosis

    Measure: Diagnosis data

    Time: From the diagnosis of the COVID until the patient is cured or dies, whichever comes first, assessed up to 5 years

    Description: Describe characteristics and evolution of Spanish patients preferably with lung cancer who contract COVID 19 infection with identification and study of factors of interest, as well as treatments received

    Measure: Treatments received

    Time: From the diagnosis of the COVID until the patient is cured or dies, whichever comes first, assessed up to 5 years

    Description: Describe characteristics and evolution of Spanish patients preferably with lung cancer who contract COVID 19 infection with identification and study of factors of interest, as well as prognostic factors.

    Measure: Prognostic factors

    Time: From the diagnosis of the COVID until the patient is cured or dies, whichever comes first, assessed up to 5 years
    6 Study of Acquired Immunity in Patients With Lung Cancer and COVID-19 Infection

    Observational, retrospective data collection and prospective IgG analysis, and multicenter study. The main objective of the study is th description of the characteristics and evolution of patients with lung cancer who have acquired COVID-19 infection. For the identification of patients who contract COVID-19 infection, the IgG+ blood test by ELISA method will be used.

    NCT04407143
    Conditions
    1. Lung Cancer
    2. COVID
    3. Corona Virus Infection
    Interventions
    1. Diagnostic Test: IgG test
    MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Lung Neoplasms
    HPO:Neoplasm of the lung

    Primary Outcomes

    Description: Description of the characteristics and evolution of patients with lung cancer who have contracted COVID-19 infection.

    Measure: Description of the characteristics of patients

    Time: From the diagnosis of the COVID until the determination of the blood IgGs, up to 10 weeks
    7 FLT3 Ligand (CDX-301), CD40 Agonist Antibody (CDX-1140), and Stereotactic Radiotherapy Versus Standard Therapy for Advanced Non-small Cell Lung Cancer: A Phase I/II Randomized Trial

    The purpose of this study is to test a new way of treating the most common form of lung cancer. The investigators are testing a combination of radiotherapy with two new forms of immunotherapy. This study is testing the safety and effectiveness of this treatment approach as compared to standard treatment options.

    NCT04491084
    Conditions
    1. Non Small Cell Lung Cancer
    2. Lung Cancer
    Interventions
    1. Drug: FLT3 Ligand (CDX-301)
    2. Biological: anti-CD40 antibody (CDX-1140)
    3. Radiation: SBRT
    MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
    HPO:Neoplasm of the lung Non-small cell lung carcinoma

    Primary Outcomes

    Description: Death Any ≥ Grade 3 non-hematological toxicity, with the following exceptions: Grade 3 alopecia, vitiligo, or endocrinopathies controlled by hormone replacement therapy Grade 3 nausea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 vomiting and diarrhea that resolves to ≤ grade 2 with or without treatment within 72 hours Grade 3 fatigue that resolves to ≤ grade 2 within 5 days Grade 3 hypertension in the absence of maximal medical therapy Grade 3 adverse event of tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor) of ≤ 7 days in duration Grade 3 amylase or lipase abnormalities that are not associated with symptoms or clinical manifestations of pancreatitis. It is recommended to consult with the Principal Investigator for grade 4 amylase or lipase abnormalities Grade 3 clinically significant laboratory abnormalities that are asymptomatic and can be reversed within 72 hours, however: Any Grade 4

    Measure: Phase I: Dose-limiting toxicity (DLT), defined as follows:

    Time: up to 8 weeks after initiation of study therapy

    Measure: Phase II: Progression-free survival (PFS) duration

    Time: defined as time from study registration until disease progression (scored using iRECIST) or death, whichever comes first up to 51 weeks.

    Secondary Outcomes

    Description: Length of time that patient survives from time of study registration

    Measure: Overall survival (OS) duration

    Time: From date of registration until the date of death from any cause, assessed up to 2 years

    Description: The clinical benefit rate (CBR) will be defined as the percentage of subjects who achieve best response of confirmed CR or PR, or stable disease (SD) for at least four months.

    Measure: Radiographic responses using descriptive statistics

    Time: From date of registration, assessed up to 4 months

    Description: Summary statistics (mean, standard deviation, median, 25th and 75th percentiles, and range) and the mean change from baseline of linear-transformed scores will be reported for all the items and subscales of the EORTC QLQ-C30 questionnaire and the QLQ-LC13, according to the EORTC scoring manual guidelines. higher scores are a better level of functioning

    Measure: Quality of Life using EORTC QLQ-LC13 (quality of Life Questionnaire, Lung Cancer)

    Time: 1 year

    Description: Summary statistics (mean, standard deviation, median, 25th and 75th percentiles, and range) and the mean change from baseline of linear-transformed scores will be reported for all the items and subscales of the EORTC QLQ-C30 questionnaire and the QLQ-LC13, according to the EORTC scoring manual guidelines. Most items are scored 1 to 4, higher scores are a better level of functioning.

    Measure: Quality of Life using QLQ-C30 (Quality of Life Questionnaire)

    Time: 1 year

    Description: Average daily step counts

    Measure: Daily step count using descriptive statistics

    Time: 1 year
    8 Understanding the Physical, Social and Psychological Impact of COVID-19 on Frail and Shielded Lung Cancer Patients

    During the COVID-19 pandemic, people's lives have changed dramatically. People with lung cancer who are shielding may have been particularly affected as they may be unable to carry out many of their normal daily activities, such as grocery shopping and exercise, and are unable to interact with friends and family. People with lung cancer will also have experienced some changes to the clinical services available to them at The Christie. Using a questionnaire and interviews, the investigators want to understand patient experiences of the changes in their daily lives and the changes to their clinical care. This will help us to see if people with lung cancer need any additional support services or if there are any changes the investigators can make to clinical services to improve patient experiences. Eligible patients will be any lung cancer patients receiving current treatment or in active follow up.

    NCT04538456
    Conditions
    1. Lung Cancer
    2. PROM
    3. Covid19
    4. Psychological
    Interventions
    1. Other: questionnaire and optional interview
    MeSH:Lung Neoplasms
    HPO:Neoplasm of the lung

    Primary Outcomes

    Description: Physical and social impact will be captured by the EuroQual-5D quality of life and questions regarding patient's diagnosis and treatment pathway including a list of symptoms based on the Common Terminology Criteria for Adverse Events.

    Measure: Physical and Social impact

    Time: baseline

    Description: Emotional impact will be assessed using the Hospital Anxiety Depression Scale. Scores range from 0-21 for each of the two subscales (anxiety and depression), with higher scores indicating greater anxiety and depression.

    Measure: Psychological impact

    Time: baseline

    Secondary Outcomes

    Description: Frailty will be assessed using the Rockwood Clinical Frailty Scale. With scores ranging from 1-9, with higher scores indicating higher frailty.

    Measure: prevalence and impact of frailty

    Time: baseline
    9 A Platform Study of DNA Damage Response Inhibitors in Combination With Conventional Radiotherapy in Non Small Cell Lung Cancer

    CONCORDE is a multi-institution, multi-arm, Phase IB study that will determine the recommended phase II dose (RP2D) and safety profiles of different DNA damage repair inhibitors (DDRis) when given in an open label fashion in combination with fixed dose curative intent radiotherapy (RT) in patients with stage IIB/IIIA/IIIB NSCLC. The RP2D will be evaluated by incorporating the number of observed dose limiting toxicities (DLTs) into a time to event continuous reassessment method (TiTE- CRM) model within each of the experimental arms. TiTE-CRM is used here to take into account longer-term toxicities up to 13.5 months post start of radiotherapy and use these to inform dose escalation decision making.

    NCT04550104
    Conditions
    1. Non Small Cell Lung Cancer
    Interventions
    1. Radiation: Radiotherapy
    2. Drug: Olaparib Oral Tablet [Lynparza]
    3. Drug: AZD1390
    4. Drug: TBD Compound 1
    5. Drug: TBD Compound 2
    6. Drug: TBD Compound 3
    MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
    HPO:Neoplasm of the lung Non-small cell lung carcinoma

    Primary Outcomes

    Description: Dose-limiting toxicities (DLTs), within 13.5 months of starting radiotherapy, in order to establish the Recommended Phase II Dose (RP2D) of each DDRi-RT combination.

    Measure: Dose limiting Toxicities

    Time: 13.5 months after start of radiotherapy

    Secondary Outcomes

    Description: Safety will be reported based on the occurrence of SAEs, SARs and SUSARs. Toxicity will be reported based on adverse events, as graded by CTCAE V5.0, and determined by routine clinical assessments at each centre.

    Measure: Safety and toxicity

    Time: 2 years after end of RT

    Description: Treatment compliance will be measured by overall radiotherapy treatment time and delays, omissions and reductions to treatment doses (both DDRi and RT).

    Measure: Treatment compliance

    Time: End of trial treatment (DDRi and RT)

    Description: Best overall response will be measured as the best response (complete response, partial response or stable disease) recorded until disease progression, reported up to 2 years post-RT. This will be assessed using RECIST 1.1

    Measure: Best overall response

    Time: 2 years after end of RT

    Description: This will be assessed using the Green Criteria. Disease Control includes either the complete disappearance of all evidence of malignant disease or residual radiographic abnormalities assessed by chest CT scan at 3 and 6 months after completion of RT, which then remains stable for an additional 6 months or more and which then qualifies as controlled local disease.

    Measure: Disease control

    Time: 2 years after end of RT

    Description: Participants who have not progressed at the time of analysis will be censored at the last date they were known to be alive and progression free

    Measure: Progression-free survival

    Time: 2 years post-RT

    Description: Participants who have not died at the time of analysis will be censored at the last date they were known to be alive

    Measure: Overall survival

    Time: 2 years post-RT

    Description: Health Related Quality of Life will be determined using EORTC QLQ-C30, IL-73 and IL-74

    Measure: Changes in Health Related Quality of Life

    Time: 2 years after end of RT

    Description: Objective response rate (ORR) is defined as the proportion of patients who have a partial or complete response to therapy. The proportion of patients with evaluable scans that achieve at least a partial response, as defined by RECIST v1.1(31), will be presented with 95% confidence intervals.

    Measure: Objective response rate

    Time: 2 years after end of RT

    Measure: Changes in tumour size during and following treatment with DDRi-RT compared to RT alone.

    Time: 2 years after end of RT

    Other Outcomes

    Description: Exploratory endpoint

    Measure: Assessment of mutations in components of DDR pathway in archival tumour and cfDNA prior to therapy

    Time: 2 years after end of RT

    Description: Exploratory endpoint

    Measure: Assessment of T cells within the archival tumour specimens

    Time: 2 years after end of RT

    Description: Exploratory endpoint

    Measure: Changes in cfDNA during and following treatment with DDRi-RT compared to RT alone.

    Time: 2 years after end of RT

    Description: Exploratory endpoint

    Measure: Changes in circulating biomarkers of cardiac and respiratory toxicity during and following treatment with DDRi-RT compared to RT alone.

    Time: 3 months post end of RT

    Description: Exploratory endpoint

    Measure: Changes in circulating peripheral T cell sub-sets during and following treatment with DDRi-RT compared to RT alone.

    Time: 2 years after end of RT

    Description: Exploratory endpoint

    Measure: Changes in lung parenchyma during and following treatment with DDRi-RT compared to RT alone.

    Time: 2 years after end of RT
    10 PHASE 1/2A DOSE ESCALATION, FINDING AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07104091 AS A SINGLE AGENT AND IN COMBINATION THERAPY

    To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF 07104091 as a single agent in participants with small cell lung, non small cell lung ovarian and breast cancers.

    NCT04553133
    Conditions
    1. Small Cell Lung Cancer
    2. Ovarian Cancer
    3. Triple Negative Breast Cancer
    4. Non-small Cell Lung Cancer
    5. Human Receptor-positive Human Epidermal Growth Factor Receptor 2
    Interventions
    1. Drug: PF-07104091 monotherapy
    2. Drug: PF-07104091 + palbociclib
    3. Drug: PF-07104091 + palbociclib + letrozole
    MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung Ovarian Neoplasms Small Cell Lung Carcinoma Triple Negative Breast Neoplasms
    HPO:Neoplasm of the lung Non-small cell lung carcinoma Ovarian neoplasm Small cell lung carcinoma

    Primary Outcomes

    Description: Number of participants with DLTs, which are typically Grade 3 or higher adverse events will be summarized by dose level

    Measure: Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle

    Time: 28 days

    Description: Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities will be summarized by dose level

    Measure: To evaluate incidence of treatment emergent adverse events and laboratory abnormalities

    Time: From baseline until end of study treatment or study completion (approximately 2 years)

    Description: Identify pulse rate readings that are outside the normal range. The number and percentage of participants who experienced significant pulse rate change from baseline will be summarized by dose level

    Measure: Evaluate pulse rate that is out of normal range and changes in pulse rate as compared to baseline

    Time: From baseline until end of study treatment or study completion (approximately 2 years)

    Description: Identify systolic and diastolic readings that are outside the normal range. The number and percentage of participants who experienced significant blood pressure change from baseline will be summarized by dose level

    Measure: Evaluate blood pressure that is out of normal range and changes in blood pressure as compared to baseline

    Time: From baseline until end of study treatment or study completion (approximately 2 years)

    Description: Determine the effect of the drug on QT prolongation. The number and percentage of participants who experienced QT interval prolongation will be summarized by dose level

    Measure: To evaluate heart rate corrected QT interval and changes in corrected QT interval as compared to baseline

    Time: From baseline until end of study treatment or study completion (approximately 2 years)

    Description: Percentage of participants with a best overall response of complete response (CR) or partial response (PR) using RECIST 1.1

    Measure: To evaluate the preliminary antitumor activity of PF-07104091 as a single agen and in combination with palbociclib and in combination with letrozole by objective response rate (ORR) in dose expansion

    Time: From baseline through disease progression or study completion (approximately 2 years)

    Secondary Outcomes

    Description: Peak concentration of PF-07104091 during selected cycles

    Measure: Maximum plasma concentration (Cmax) of PF-07104091 after a single dose and multiple dose

    Time: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)

    Description: Time to peak concentration of PF-07104091 during selected cycles

    Measure: Time to maximum plasma concentration (Tmax) of PF-07104091 after a single dose and multiple dose

    Time: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)

    Description: AUC of PF-07104091 will be calculated at selected cycles

    Measure: Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-07104091

    Time: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)

    Description: AUC of PF-07104091 in plasma and whether absorption of the drug is affected when taken by food

    Measure: Area under the curve of PF-07104091 with or without food

    Time: From baseline through time to event on study or study completion (approximately 2 years)

    Description: Peak concentrations of PF-07104091 in plasma and whether absorption of the drug is affected when taken by food

    Measure: Maximum plasma concentration of PF-07104091 with or without food

    Time: From baseline through time to event on study or study completion (approximately 2 years)

    Description: Percentage of participants with a best overall response of CR or PR using RECIST 1.1

    Measure: To document any preliminary evidence of antitumor activity of PF-07104091 as a single agen and in combination with palbociclib and in combination with letrozole by objective response rate (ORR) in dose escalation

    Time: From baseline and every 8 weeks through disease progression or study completion (approximately 2 years)

    Description: Time from first assessment of event endpoint to last assessment of using RECIST 1.1

    Measure: To document any preliminary evidence of antitumor activity of PF-07104091 by time to event endpoints

    Time: From baseline through time to event on study or study completion (approximately 2 years)
    11 Preventing Viral Pandemic Associated Risk of Cancer Death Using Less Invasive Diagnostic Tests- Liquid Biopsies

    The purpose of this study is to investigate the feasibility of using ctDNA to support cancer diagnosis and risk stratification where invasive aerosol generating testing (and/or tissue biopsy) is challenging due to infection risk, technical impracticalities and resource limitations, such as during the COVID-19 pandemic and the subsequent recovery period.

    NCT04566614
    Conditions
    1. Neoplasm, Colorectal
    2. Ne
    3. Neoplasm of Lung
    4. Neoplasm, Bladder
    5. Neoplasms Pancreatic
    6. Biliary Tract Neoplasms
    7. Gastro Intestinal Stromal Tumour
    Interventions
    1. Other: ctDNA blood sampling
    MeSH:Neoplasms Biliary Tract Neoplasms Lung Neoplasms Colorectal Neoplasms Gastrointestinal Stromal Tumors Urinary Bladder Neoplasms
    HPO:Biliary tract neoplasm Bladder neoplasm Gastrointestinal stroma tumor Neoplasm Neoplasm of the large intestine Neoplasm of the lung

    Primary Outcomes

    Description: The primary endpoint, ctDNA detection rate, overall and within different cancer types will be presented as a proportion of patients with a positive ctDNA test out of those tested, with 90% confidence intervals

    Measure: ctDNA detection rate within different cancer types (and overall)

    Time: Throughout study completion, up to one year

    Secondary Outcomes

    Description: All secondary endpoints will be analysed in the patients diagnosed with suspected cancer, i.e. positive ctDNA result, unless stated. They will also be presented overall and by cancer type. The proportion of patients with positive ctDNA result which identified a diagnosis and/or commenced treatment will be presented as a proportion with 90% confidence intervals

    Measure: Proportion of patients with a positive ctDNA result which identified a diagnosis and/or commenced treatment

    Time: Throughout study completion, up to one year

    Description: Proportion of patients with positive ctDNA result which assisted in prioritising invasive diagnostic tests will be presented as a proportion with 90% confidence intervals

    Measure: Proportion of patients with a positive ctDNA result which assisted in prioritising invasive diagnostic tests

    Time: Throughout study completion, up to one year

    Description: The association between ctDNA result (positive versus negative) and the PREVAIL-imaging pathway scoring result will be assessed descriptively by presenting cross-tabulations and relevant proportions

    Measure: The association of ctDNA result (positive versus negative) and the PREVAIL-imaging pathway scoring result

    Time: Throughout study completion, up to one year

    Description: Simple estimation of the cost of liquid biopsy in lieu of tissue biopsy as compared to standard of care investigations and treatments prioritisation will be performed

    Measure: Estimation of the cost of liquid biopsy in lieu of tissue biopsy as compared to standard of care investigations and treatments prioritisation

    Time: Throughout study completion, up to one year
    12 Telerehabilitation of Reduced Physiotherapy Service in SARS-CoV-2 Pandemic Process in Lung Surgery Patients

    In this study, providing access to physiotherapy applications by telerehabilitation method and the effectiveness of this application will be examined for patients who have undergone lung surgery in the early postoperative period during the pandemic process in which social isolation continues.

    NCT04568564
    Conditions
    1. Lung Cancer
    2. Physiotherapy
    Interventions
    1. Other: Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulation
    2. Other: Exercise booklet
    MeSH:Lung Neoplasms
    HPO:Neoplasm of the lung

    Primary Outcomes

    Description: Major complication rates such as postoperative fever, infection, and hemorrhage will be documented.

    Measure: Major complication rate

    Time: Up to 3 months

    Secondary Outcomes

    Description: The six-minute walking test is an example of timed distance testing, widely used in clinical research and rehabilitation studies. According to the guidelines published by the American Thoracic Society, 6MWT is an easy-to-use, better tolerated test that reflects daily activities better than other walking tests. It can be applied in a short time. Requires little equipment. The six-minute walk test, used as a field test, is a simple and inexpensive test compatible with daily activities, which does not require exercise equipment. Before starting the test, the patient should rest for at least 10 minutes by sitting in the chair near the starting point. The walking area must be at least 30 m long. A shorter corridor causes more time to be spent for more frequent turns and changes of direction. With the help of stopwatch, it is kept for 6 minutes and the number of laps during the period is calculated and recorded. The functional capacity of the cases will be evaluated with 6MWT.

    Measure: The six-minute walking test

    Time: Up to 3 months

    Description: It is a scale used to determine the severity of dyspnea with a rating of zero to 4. Zero means no dyspnea perception and 4 means severe dyspnea.

    Measure: Modified Medical Research Council Dyspnea Scale

    Time: Up to 3 months

    Description: The pain, dyspnea and fatigue level of the cases were evaluated with visual analog scale (VAS) score. The scale presented as a 100 mm horizontal ruler is a documented method for scoring continuous soft data. "0" score means no pain, "100" means very severe pain

    Measure: Visual analog scale

    Time: Up to 3 months

    Measure: Duration of tube thoracostomy drainage

    Time: Up to 3 months

    Description: FEV1 measurements will be reported as absolute values (e.g. liters, measured) and percentage of predicted (FEV1measured/ FEV1 predicted).

    Measure: Forced expiratory volume one second (FEV1)

    Time: Up to 3 months

    Description: FVC measurements will be reported as absolute values (e.g. liters, measured) and percentage of predicted (FVCmeasured/ FVC predicted).

    Measure: Forced vital capacity (FVC)

    Time: Up to 3 months

    Description: DLCO and DLCO / VA values will be analyzed

    Measure: Diffusion Capacity

    Time: Change from baseline to 1 and 3 months

    Description: Lung capacities will be given the measured value and their percentages will be calculated according to the estimated values.

    Measure: Lung Capacities

    Time: Change from baseline to 1 and 3 months

    Description: Tumor side and contralateral lung V / Q scintigraphy measurements will be made.

    Measure: Lung V/Q Scintigraphy

    Time: Change from baseline to 1 and 3 months

    Description: Procalcitonin is a substance produced by many types of cells in the body, often in response to bacterial infections but also in response to tissue injury. The level of procalcitonin in the blood can increase significantly in systemic bacterial infections and sepsis.The reference value of PCT in adults and children older than 72 hours is 0. 15 ng/mL or less.

    Measure: Procalcitonin (PCT)

    Time: Up to 3 months

    Description: C-reactive protein is a substance produced by the liver in response to inflammation. For a standard CRP test, a normal reading is less than 10 milligram per liter (mg/L). A test result showing a CRP level greater than 10 mg/L is a sign of serious infection, trauma or chronic disease, which likely will require further testing to determine the cause

    Measure: C-Reactive Protein (CRP)

    Time: Up to 3 months

    Description: Ferritin is a blood protein that contains iron. The normal ferritin levels range from 12 to 300 nanograms per milliliter of blood (ng/mL) for males and 12 to 150 ng/mL for females.

    Measure: Ferritin

    Time: Up to 3 months

    Description: Lactate dehydrogenase is an enzyme that helps turn sugar into energy for your cells. High LDH levels could indicate cell damage.Normal LDH levels range from 140 units per liter (U/L) to 280 U/L or 2.34 microkatals/L to 4.68 microkatals/L.

    Measure: Lactate dehydrogenase

    Time: Up to 3 months

    Description: D-dimer tests are used to help rule out the presence of an inappropriate blood clot (thrombus). The reference concentration of D-dimer is < 250 ng/mL, or < 0.4 mcg/mL.

    Measure: D'dimer test

    Time: Up to 3 months

    Description: The partial pressure of carbon dioxide (PCO2) is the measure of carbon dioxide within arterial or venous blood. It often serves as a marker of sufficient alveolar ventilation within the lungs. Generally, under normal physiologic conditions, the value of PCO2 ranges between 35 to 45 mmHg.

    Measure: Partial Carbon monoxide Pressure (PaCO2)

    Time: Up to 3 months

    Description: The partial pressure of oxygen, also known as PaO2, is a measurement of oxygen pressure in arterial blood. 75 to 100 millimeters of mercury (mm Hg) is the normal ranges.

    Measure: Partial Oxigen Pressure (PaO2)

    Time: Up to 3 months

    Description: It reflects the saturation level of hemoglobin with oxygen. Its normal values are 95-100%.

    Measure: Arterial blood oxygen saturation level (SaO2)

    Time: Up to 3 months

    Description: The state-trait anxiety scale will determine the anxiety levels of patients before and after surgery. It is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic.While evaluating, a score between 1 (or -1) and 4 (or -4) is given for each item according to the positive or negative characteristics of the item, and the total score to be obtained is 50 constant is added. The highest score is 80, the lowest is 20. Total anxiety the higher the score, the more anxiety level of the person filling the scale.

    Measure: Anxiety inventory

    Time: Up to 3 months

    HPO Nodes


    Reports

    Data processed on September 26, 2020.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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