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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4155 | Stereotactic Radiotherapy Wiki | 0.25 |
| drug5231 | standard chemotherapy Wiki | 0.25 |
| drug4547 | UCPVax + Nivolumab Wiki | 0.25 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug5170 | questionnaire and optional interview Wiki | 0.25 |
| drug3818 | SLEDD with a L-MOD Wiki | 0.25 |
| drug1148 | Convalescent anti-SARS-CoV-2 MBT plasma Wiki | 0.25 |
| drug3038 | PF-07104091 + palbociclib + letrozole Wiki | 0.25 |
| drug2067 | IgG test Wiki | 0.25 |
| drug4177 | Sublingual Methylene blue Wiki | 0.25 |
| drug3428 | Prototype swab Wiki | 0.25 |
| drug4255 | TBD Compound 3 Wiki | 0.25 |
| drug2931 | Olaparib Oral Tablet [Lynparza] Wiki | 0.25 |
| drug1129 | Control patients Wiki | 0.25 |
| drug172 | AZD1390 Wiki | 0.25 |
| drug3800 | SBRT Wiki | 0.25 |
| drug1565 | Exercise booklet Wiki | 0.25 |
| drug4254 | TBD Compound 2 Wiki | 0.25 |
| drug241 | AeroEclipse II Breath Actuated Nebulizer Wiki | 0.25 |
| drug1767 | Gam-COVID-Vac Lyo Wiki | 0.25 |
| drug1120 | Control Group Wiki | 0.25 |
| drug1412 | EHR-based Clinician Jumpstart Wiki | 0.25 |
| drug1616 | FLT3 Ligand (CDX-301) Wiki | 0.25 |
| drug2436 | Lung Cancer Screening Decision Tool Wiki | 0.25 |
| drug4825 | anti-CD40 antibody (CDX-1140) Wiki | 0.25 |
| drug1471 | Electrocautery Ablation (EC) Wiki | 0.25 |
| drug1130 | Control swab Wiki | 0.25 |
| drug2603 | Methylene Blue Wiki | 0.25 |
| drug4253 | TBD Compound 1 Wiki | 0.25 |
| drug451 | Azacytidine Wiki | 0.25 |
| drug309 | Anatomic Pulmonary Resection Wiki | 0.25 |
| drug1124 | Control Test Wiki | 0.25 |
| drug1178 | Cosentyx Wiki | 0.25 |
| drug3039 | PF-07104091 monotherapy Wiki | 0.25 |
| drug3037 | PF-07104091 + palbociclib Wiki | 0.25 |
| drug4910 | ctDNA blood sampling Wiki | 0.25 |
| drug694 | Breathing exercise, intensive spirometry use, supported cough, progressive mobilisation and ambulation Wiki | 0.25 |
| drug601 | Bintrafusp alfa Wiki | 0.25 |
| drug1122 | Control Intervention Wiki | 0.25 |
| drug904 | Candin Wiki | 0.18 |
| drug3567 | Radiotherapy Wiki | 0.18 |
| drug4640 | Venetoclax Wiki | 0.14 |
| drug1238 | DWRX2003 Wiki | 0.14 |
| drug3124 | Pembrolizumab Wiki | 0.14 |
| drug1127 | Control group Wiki | 0.14 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung NIH | 0.51 |
| D012509 | Sarcoma NIH | 0.25 |
| D046152 | Gastrointestinal Stromal Tumors NIH | 0.25 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D009373 | Neoplasms, Germ Cell and Embryonal NIH | 0.25 |
| D001661 | Biliary Tract Neoplasms NIH | 0.25 |
| D001749 | Urinary Bladder Neoplasms NIH | 0.25 |
| D009362 | Neoplasm Metastasis NIH | 0.19 |
| D009369 | Neoplasms, NIH | 0.15 |
| D010051 | Ovarian Neoplasms NIH | 0.14 |
| D055752 | Small Cell Lung Carcinoma NIH | 0.14 |
| D016491 | Peripheral Vascular Diseases NIH | 0.14 |
| D008545 | Melanoma NIH | 0.14 |
| D008103 | Liver Cirrhosis, NIH | 0.13 |
| D058729 | Peripheral Arterial Disease NIH | 0.13 |
| D014652 | Vascular Diseases NIH | 0.13 |
| D064726 | Triple Negative Breast Neoplasms NIH | 0.11 |
| D015179 | Colorectal Neoplasms NIH | 0.10 |
| D007676 | Kidney Failure, Chronic NIH | 0.10 |
| D051437 | Renal Insufficiency, NIH | 0.08 |
| D017563 | Lung Diseases, Interstitial NIH | 0.06 |
| D002908 | Chronic Disease NIH | 0.06 |
| D006333 | Heart Failure NIH | 0.06 |
| D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.06 |
| D008171 | Lung Diseases, NIH | 0.04 |
| 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 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0100526 | Neoplasm of the lung HPO | 0.94 |
| HP:0030358 | Non-small cell lung carcinoma HPO | 0.51 |
| HP:0100242 | Sarcoma HPO | 0.25 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0100723 | Gastrointestinal stroma tumor HPO | 0.25 |
| HP:0100574 | Biliary tract neoplasm HPO | 0.25 |
| HP:0002898 | Embryonal neoplasm HPO | 0.25 |
| HP:0009725 | Bladder neoplasm HPO | 0.25 |
| HP:0002664 | Neoplasm HPO | 0.15 |
| HP:0030357 | Small cell lung carcinoma HPO | 0.14 |
| HP:0100615 | Ovarian neoplasm HPO | 0.14 |
| HP:0012056 | Cutaneous melanoma HPO | 0.14 |
| HP:0001395 | Hepatic fibrosis HPO | 0.13 |
| HP:0100834 | Neoplasm of the large intestine HPO | 0.10 |
| HP:0004950 | Peripheral arterial stenosis HPO | 0.09 |
| HP:0000083 | Renal insufficiency HPO | 0.08 |
| HP:0006515 | Interstitial pneumonitis HPO | 0.06 |
| HP:0001635 | Congestive heart failure HPO | 0.06 |
| HP:0006510 | Chronic pulmonary obstruction HPO | 0.06 |
| HP:0002088 | Abnormal lung morphology HPO | 0.04 |
Navigate: Correlations HPO
There are 16 clinical trials
This study evaluates whether EC treatment is effective in delaying the progression of high-grade lung lesion(s) to invasive lung cancer. Participants will be randomised to receive either electrocautery (EC) treatment with autofluorescence bronchoscopy (AFB) surveillance (=intervention), or AFB surveillance alone (=control) in a 2:1 ratio.
Description: The time to progression of any index HGL in a patient to invasive lung cancer
Measure: The time to progression of any index HGL in a patient within a 3-year follow up (phase II and III) Time: 3 years post randomisationVeterans 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).
Description: Decision regret as measured by a 5-item Decision Regret scale that is patient reported.
Measure: Decision Regret Time: 1 month following interventionDescription: Decisional conflict as measured by a 16 item Decisional Conflict scale that is patient reported
Measure: Decisional Conflict Time: 1 month following the interventionDescription: State anxiety as measured by the State Trait Anxiety Index
Measure: Anxiety Time: 1 month following interventionDescription: Lung cancer worry as measured by a 7 item scale that is patient reported
Measure: Lung cancer worry Time: 1 month after the interventionDescription: Assessed by chart review
Measure: Lung cancer screening uptake Time: 6 months after the interventionPatients 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.
Description: Survival estimates will include death from any cause.
Measure: Overall Survival Time: From date of randomization through study completion, up to 10 yearsDescription: 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 yearsDescription: 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 yearsDescription: The EQ-5D-5L (EuroQOL-5D) survey will measure quality adjusted life years.
Measure: Health State Utilities Time: 5 yearsDescription: 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 yearsDescription: The Forced Expiratory Volume at 1 second (FEV1) will evaluate an objective measure of breathing function.
Measure: Respiratory Function Time: 5 yearsThis study evaluates whether EC treatment is effective in delaying the progression of high-grade lung lesion(s) to invasive lung cancer. Participants will be randomised to receive either electrocautery (EC) treatment with autofluorescence bronchoscopy (AFB) surveillance (=intervention), or AFB surveillance alone (=control) in a 2:1 ratio.
Description: The time to progression of any index HGL in a patient to invasive lung cancer
Measure: The time to progression of any index HGL in a patient within a 3-year follow up (phase II and III) Time: 3 years post randomisationLung 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).
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)Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. It is the most common form of lung cancer, accounting for around 85% of lung cancers. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of venetoclax in combination with pembrolizumab in participants with NSCLC. Venetoclax is a drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. Pembrolizumab is approved drug for the treatment of NSCLC. It works with your immune system to help fight certain cancers. The study is split into two portions - dose escalation and randomization. Participants are assigned one of the three treatment groups to receive pembrolizumab alone or in combination with venetoclax. Each group receives a different treatment. Participants who are at least 18 years of age with a diagnosis of NSCLC will be enrolled. Around 100 participants will be enrolled in the study in approximately 44 sites across United States. Participants will receive intravenous (IV) infusion of pembrolizumab alone or in combination with oral venetoclax tablets. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Description: DLTs are adverse events that are considered to have a reasonable possibility of relationship to the administration of venetoclax and pembrolizumab and cannot be attributed by the investigator to a clearly identifiable cause such as disease progression, concurrent illness or concomitant medication.
Measure: Number of Participants with Dose-Limiting Toxicities (DLTs) Time: Up to 28 DaysDescription: Change in the SLD is assessed by exposure-response modeling
Measure: Change in the Sum of the Longest Diameter (SLD) Time: Up to 35 Cycles (Each Cycle is 21 Days)Description: Maximum plasma concentration (Cmax) of venetoclax
Measure: Maximum Plasma Concentration (Cmax) of Venetoclax Time: Up to Cycle 1 (Each Cycle is 21 Days)Description: Time to maximum observed plasma concentration (Tmax) of venetoclax
Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax Time: Up to Cycle 1 (Each Cycle is 21 Days)Description: Area Under the Plasma Concentration-time Curve (AUC) from 0-24 (AUC0-24)
Measure: Area Under the Plasma Concentration-Time Curve Over Time from 0 to 24 (AUC0-24) of Venetoclax in Plasma Time: Up to Cycle 1 (Each Cycle is 21 Days)Description: ORR will be defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR).
Measure: Objective Response Rate (ORR) Time: Up to 35 Cycles (Each Cycle is 21 Days)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.
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 randomizationDescription: 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 randomizationDescription: 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 randomizationDescription: 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 randomizationDescription: 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 randomizationDescription: 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 randomizationDescription: 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 randomizationDescription: From Washington State death certificates.
Measure: All-cause mortality at 1 year (safety outcome) Time: 1 year after randomizationDescription: 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 randomizationThis 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.
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 yearsDescription: 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 yearsDescription: 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 yearsDescription: 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 yearsObservational, 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.
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 weeksThe 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.
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 therapyDescription: 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 yearsDescription: 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 monthsDescription: 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 yearDescription: 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 yearDescription: Average daily step counts
Measure: Daily step count using descriptive statistics Time: 1 yearDuring 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.
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: baselineDescription: 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: baselineDescription: 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: baselineCONCORDE 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.
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 radiotherapyDescription: 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 RTDescription: 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 RTDescription: 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 RTDescription: 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-RTDescription: 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-RTDescription: 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 RTDescription: 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 RTDescription: 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 RTDescription: Exploratory endpoint
Measure: Assessment of T cells within the archival tumour specimens Time: 2 years after end of RTDescription: Exploratory endpoint
Measure: Changes in cfDNA during and following treatment with DDRi-RT compared to RT alone. Time: 2 years after end of RTDescription: 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 RTDescription: 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 RTDescription: Exploratory endpoint
Measure: Changes in lung parenchyma during and following treatment with DDRi-RT compared to RT alone. Time: 2 years after end of RTTo 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.
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 daysDescription: 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)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)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.
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 yearDescription: 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 yearDescription: 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 yearDescription: 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 yearDescription: 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 yearIn 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.
Description: Major complication rates such as postoperative fever, infection, and hemorrhage will be documented.
Measure: Major complication rate Time: Up to 3 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: DLCO and DLCO / VA values will be analyzed
Measure: Diffusion Capacity Time: Change from baseline to 1 and 3 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsBackground: About one-third to one-half of all people dying of extrathoracic malignant diseases have cancer that has spread to the lungs. Surgery may help some people. But most people with pulmonary metastases do not survive long. Researchers want to see if a combination of drugs can help. Objective: To find a safe dose of Azacytidine, when taken as a fine mist that is inhaled (aerosolized Azacytidine), together with Bintrafusp Alfa to treat cancers that have spread to the lungs. Eligibility: Adults ages 18 and older who have cancer that has spread to the lungs, cannot be cured with surgery, and has not responded to standard treatments. Design: Participants will get Azacytidine by breathing treatments once a day for 3 days each week, for 3 weeks. The 3-week period is 1 cycle. Each course of treatment is 3 cycles. Once per cycle, participants will get Bintrafusp Alfa via IV. An IV is a small tube that is put into an arm vein. Participants will keep a diary of any side effects. Participants can take the study drugs for as long as they can continue treatment. Participants will have medical histories and physical exams. They will give blood, urine, and lung lining fluid samples. Tumor samples will be taken via bronchoscopy. They will have lung function tests. Participants will have an imaging scan that shows how spray particles move in their airway when they inhale. They will have tumor imaging scans of the chest and brain. Participants will have a follow-up visit 30 days after they stop treatment.
Description: DLTs at each Phase I dose level will be reported. Pharmacokinetic analysis will be conducted using non-compartmental methods. All patients will be evaluable for toxicity from the time of their first treatment with AZA/ Bintrafusp alfa. Dose limiting toxicities will be assessed during the first 3 cycles of AZA/ Bintrafusp alfa therapy. Patients who have measurable disease present at baseline, have received at least 9 weeks of AZA/Bintrafusp alfa therapy (three cycles), and have had their disease re-evaluated will be considered evaluable for response.
Measure: Phase I: Determine pharmacokinetics, toxicities, maximum tolerated dose and recommended Phase 2 dose (RP2D) of aerosolized AZA in patients receiving IV Bintrafusp alfa for unresectable pulmonary metastases Time: baseline, first treatment, end of each courseDescription: Patients who have measurable disease present at baseline, have received at least 9 weeks of AZA/Bintrafusp alfa therapy (three cycles), and have had their disease re-evaluated will be considered evaluable for response provided.
Measure: Phase II: Determine frequency of intrathoracic objective clinical response in patients with unresectable pulmonary metastases following administration of aerosolized AZA at the RP2D and IV Bintrafusp alfa Time: baseline, end of each courseAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 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.
Drug Reports MeSH Reports HPO Reports