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Sections: Correlations,
Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1551 | Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer Wiki | 0.45 |
| drug1498 | Endoscopic management according to standard of care Wiki | 0.45 |
| drug3080 | Palliative care assessment Wiki | 0.45 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D008105 | Liver Cirrhosis, Biliary NIH | 0.45 |
| D041781 | Jaundice, Obstructive NIH | 0.45 |
| D018281 | Cholangiocarcinoma NIH | 0.45 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002894 | Neoplasm of the pancreas HPO | 1.00 |
| HP:0030153 | Cholangiocarcinoma HPO | 0.45 |
| HP:0002613 | Biliary cirrhosis HPO | 0.45 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000952 | Jaundice HPO | 0.32 |
| HP:0030151 | Cholangitis HPO | 0.32 |
| HP:0005584 | Renal cell carcinoma HPO | 0.22 |
| HP:0030731 | Carcinoma HPO | 0.13 |
Navigate: Correlations HPO
There are 5 clinical trials
This study evaluates ADCT-301 in patients with Selected Advanced Solid Tumors. Patients will participate in a Treatment Period with 3-week cycles and a Follow-up Period every 12 weeks for up to 1 year after treatment discontinuation.
Description: An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.
Measure: Assessment of Dose Limiting Toxicities in Determination of the Maximum Tolerated Dose Limiting toxicities as defined per protocol, as related to ADCT-301 Time: Up to 3 yearsDescription: Adverse events will be graded according to CTAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5.
Measure: Number of Adverse Events of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above Time: Up to 3 yearsDescription: A SAE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization of prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the patient or may require medical or surgical intervention to prevent any of the outcomes listed above.
Measure: Number of Serious Adverse Events (SAE) Time: Up to 3 yearsDescription: AEs will be graded according to CTCAE v.4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5.
Measure: Number of SAEs of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above Time: Up to 3 yearsDescription: Overall response rate (ORR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Measure: Evaluate the preliminary anti-tumor activity of camidanlumab tesirine Time: Up to 3 yearsDescription: Duration of response (DOR) defined as the time from the first documentation of tumor response to disease progression as per RECIST v1.1
Measure: Evaluate the preliminary anti-tumor activity of camidanlumab tesirine Time: Up to 3 yearsDescription: Progression-free survival (PFS) defined as the time between start of treatment and the first documentation of recurrence or progression as per RECIST v1.1
Measure: Evaluate the preliminary anti-tumor activity of camidanlumab tesirine Time: Up to 3 yearsDescription: Overall survival (OS) defined as the time between the start of treatment and death from any cause
Measure: Evaluate the preliminary anti-tumor activity of camidanlumab tesirine Time: Up to 3 yearsDescription: Noncompartmental analysis of the maximum concentration (Cmax)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of the time to maximum concentration (Tmax)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of the area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0 last)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of the area under the concentration-time curve from time zero to infinity (AUC0-∞)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of the area under the concentration-time curve from time zero to the end of the dosing interval (AUC0-τ)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of the accumulation index (AI)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of clearance (CL)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: Noncompartmental analysis of volume of distribution (Vd)
Measure: Pharmacokinetics and Pharmacodynamics assessment- camidanlumab tesirine in serum Time: Up to 3 yearsDescription: ADA titers if applicable, neutralizing activity to camidanlumab tesirine after treatment with camidanlumab tesirine.
Measure: Number of confirmed positive anti-drug antibody (ADA) responses Time: Up to 3 yearsThe primary objective is to explore the impact of early palliative care on quality of life in patients with advanced pancreatic cancer. The secondary objectives are to explore the impact of early palliative care on symptom management, depression, anxiety and survival in patients with advanced pancreatic cancer.
Description: For the primary endpoint, we will use a generalized linear model to test for a statistically significant change score between baseline and 16 weeks. We will assume a normal distribution for the change scores. Model fit will be assessed via a visual assessment of residuals and the ratio of the model deviance to its degrees of freedom.
Measure: Impact of early palliative care on quality of life in patients with advanced pancreatic cancer Time: registration to 16 weeksDescription: Secondary endpoints will include: (1) symptom control at 16 weeks as measured by the revised Edmonton Symptom Assessment Scale (ESAS-r) (a widely used and validated tool to assess symptom intensity, which is routinely completed by patients at all CCMB visits); (2) depression and anxiety at 16 weeks using the Hospital Anxiety and Depression Scale (HADS) (a 14 item scale which can be used in the outpatient setting to screen for anxiety and depression within the previous week) and the Patient Health Questionnaire (PHQ-9) (a sensitive (88%) and specific (88%) 9 question tool which incorporates diagnostic criteria for major depression); and overall survival measured from date of registration to death
Measure: To explore the impact of early palliative care on symptom management, depression, anxiety and survival in patients with advanced pancreatic cancer Time: registration to 16 weeksA study to assess the biochemical and immunomodulatory effects of BXCL701 in pancreatic cancer.
Description: To measure how BXCL701 effects the tumor by measuring the rate of tumor cell death or the reduction of tumor cell growth. This will be measured by scans and blood work.
Measure: To characterize the quantitative and qualitative effects of BXCL701 on relevant immune effector cytokines and various immunological effector cells that are consistent with its known mechanism of action. Time: Up to 37 days post treatmentDescription: assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events
Measure: Evaluate the tolerability of exposure to BXCL701: National Cancer Institute Common Terminology Criteria Time: Up to 37 days post treatmentDescription: Measure the rate of cancer cell death measured by histological staining methods of post-treatment biopsied tissue.
Measure: Evaluate the effect of exposure to BCXL701 on cancer cell death Time: Up to 37days post treatmentDescription: Genomic analysis is the identification, measurement or comparison of genomic features such as DNA sequence, structural variation, gene expression, or regulatory and functional element annotation at a genomic scale.
Measure: Genomic analysis before and after treatment. Time: Up to 37 days post treatmentPancreatic cancer (PC) is recognized as one of the most challenging tumors to deal with and it is still characterized by a poor long-term prognosis. However, treatment of PC in high-volume centers with the support of a multidisciplinary approach has widely demonstrated improvement both in terms of short- and long-term outcomes. The recent worldwide spread of Covid-19 pandemic significantly affected the healthcare systems of most countries in the world, particularly in red areas such as Italy, with more than 100.000 cases in a two-month time lapse. This inevitably reflected in a reorganization of hospital activities, including the diagnostic and therapeutic pathways for PC treatment. With the aim of giving an objective and real representation of the impact of Covid-19 on PC treatment, the investigator here propose a multicenter Italian observational study comparing a 6-month period before and during the Covid-19 pandemic. Only high-volume centers will be involved in the study. A comparison between the general, clinical, endoscopic and surgical outcomes will be performed by means of a global and month-by-month analysis between the two study periods.
In this study, investigators aim to explore the status of advanced endoscopy in different endoscopy units all over the world.
Description: Investigators will report the baseline demographic data (age, gender, nationality) of all patients.
Measure: Age, gender, nationality Time: 3 monthsDescription: Investigators will report the baseline data clinical data (indication for procedure, status of SARS-CoV-2 infection) of all patients.
Measure: Indication for procedure, status of SARS-CoV-2 infection Time: 3 monthsDescription: Investigators will report the baseline laboratory data (complete blood count and liver functions tests) of all patients.
Measure: Complete blood count and liver functions tests Time: 3 monthsDescription: Investigators will report the procedure related complications.
Measure: procedure related complications Time: 3 monthsDescription: Investigators will report wether the precautions lead to increase timing of the procedure
Measure: Effect of COVID-19 precautions on procedure time Time: 3 monthsDescription: Investigators will report wether the precautions affected staff number (increased or decreased)
Measure: Effect of COVID-19 precautions on staff number Time: 3 monthsAlphabetical 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