Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2673 | Olaparib Oral Tablet [Lynparza] Wiki | 0.71 |
| drug3871 | TBD Compound 3 Wiki | 0.71 |
| drug3870 | TBD Compound 2 Wiki | 0.71 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung NIH | 0.32 |
| D008175 | Lung Neoplasms NIH | 0.20 |
| D011014 | Pneumonia NIH | 0.04 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0030358 | Non-small cell lung carcinoma HPO | 0.32 |
| HP:0100526 | Neoplasm of the lung HPO | 0.20 |
| HP:0002090 | Pneumonia HPO | 0.04 |
Navigate: Correlations HPO
There are 2 clinical trials
SARS-CoV-2 is causing an unprecedented stress on healthcare systems around the world, due to its high rate of infection and the high morbidity and mortality. The COVID-19 infection triggers an inflammatory cascade with cytokine synthesis, prompting the immune response. Low dose radiotherapy (LD-RT) (≤ 100 cGy) induces an anti-inflammatory response, lowering levels of pro-inflammatory cytokines such as IL-1β or inhibit leukocyte recruitment. LD-RT has been used historically for the pneumonia treatment reporting a rapid clinical improvement (within the first week), as well as a reduced mortality (from around 30% to 10%). Considering these results, LD-RT can potentially afford a therapeutic benefit against SARS-CoV-2. The study purpose is to evaluate prospectively the safety and efficacy of LD-RT for SARS-CoV-2.
Description: Radiological results: Radiological worsening, improvement or without significant changes
Measure: Radiological response Time: 3 days after low dose radiationDescription: Radiological results: Radiological worsening, improvement or without significant changes
Measure: Radiological response Time: 7 days after low dose radiationDescription: Remission of respiratory symptoms
Measure: Remission of respiratory symptoms Time: up to 6 monthsDescription: Time to SPO2>94% or PaO2/FiO2 >350mmHg without oxygen
Measure: SPO2 and PaO2/FiO2 Time: 7 daysDescription: Occurrence and grade of CTCAE 5.0 adverse events
Measure: Adverse events Time: 1 yearDescription: Duration of hospitalization
Measure: Hospitalization Time: 3 monthsDescription: Overall survival
Measure: Overall survival Time: 1 monthDescription: ferritin value (ng/mL)
Measure: Ferritin value Time: 1 day after low dose radiationDescription: ferritin value (ng/mL)
Measure: Ferritin value Time: 2 days after low dose radiationDescription: ferritin value (ng/mL)
Measure: Ferritin value Time: 3 days after low dose radiationDescription: blood cell count (unit/L)
Measure: blood cell count Time: 1 day after low dose radiationDescription: blood cell count (unit/L)
Measure: blood cell count Time: 2 days after low dose radiationDescription: blood cell count (unit/L)
Measure: blood cell count Time: 3 days after low dose radiationDescription: C-reactive protein (mg/dl)
Measure: C-reactive protein Time: 1 day after low dose radiationDescription: C-reactive protein (mg/dl)
Measure: C-reactive protein Time: 2 days after low dose radiationDescription: C-reactive protein (mg/dl)
Measure: C-reactive protein Time: 3 days after low dose radiationDescription: D-dimer (ng/ml)
Measure: D-dimer Time: 1 day after low dose radiationDescription: D-dimer (ng/ml)
Measure: D-dimer Time: 2 days after low dose radiationDescription: D-dimer (ng/ml)
Measure: D-dimer Time: 3 days after low dose radiationDescription: LDH levels (UI/L)
Measure: LDH levels Time: 1 day after low dose radiationDescription: LDH levels (UI/L)
Measure: LDH levels Time: 2 days after low dose radiationDescription: LDH levels (UI/L)
Measure: LDH levels Time: 3 days after low dose radiationCONCORDE 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 RTAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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.
Drug Reports MeSH Reports HPO Reports