NCT04510129Recruiting
A Multicenter Cancer Biospecimen Collection Study
Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies
Source: ClinicalTrials.gov · Last updated 12 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study will collect de-identified tumor samples, with correlated clinical/demographic data and tissue histology, from patients selected or scheduled for pre-treatment tumor biopsy or who have had a recent pre-treatment tumor biopsy. These specimens and clinical data may be used in subsequent studies for the development and validation of a diagnostic test.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1650 (estimated)
- First submitted
- 10 Aug 2020
- Start date
- 5 Feb 2020
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Cofactor Genomics, Inc.
- Diseases
- Triple-negative breast cancer, Head and neck cancer, Kidney cancer, Bladder cancer, Cervical cancer, Lung cancer, Colorectal cancer, Liver and biliary tract cancer, Gastric and esophageal cancer
- NCT number
- NCT04510129
What you commit to
- Study type: Observational
- Planned participants: 1650
- From 5 Feb 2020 to the primary completion date, 28 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subject who does/did not have one of the cancers listed above (other histologies).
Other
- Inability or unwillingness to provide informed consent.
- Subject has already participated in this trial.
Who the study is looking for
- Subject must have a disease of interest. Specifically, subject must have one of:
- head and neck squamous cell carcinoma (HNSCC)
- non-small-cell lung cancer (NSCLC)
- small cell lung cancer (SCLC)
- urothelial carcinoma (UCC)
- gastric or gastroesophageal junction adenocarcinoma
- cervical cancer
- esophageal squamous cell carcinoma (ESCC)
- triple-negative breast cancer (TNBC)
- hepatocellular carcinoma (HCC)
- renal cell carcinoma (RCC)
- colorectal cancer (CRC)
- Subject must have received, or be scheduled to receive, at least one dose of anti-PD-1/PD-L1 immunotherapy for treatment of their cancer.
- Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1/PD-L1 immunotherapy.
- Subject must have undergone, or will undergo, medical imaging (e.g. CT or MRI) of the tumor prior to treatment with anti-PD-1/PD-L1 immunotherapy.
- Willing to provide electronic informed consent per IRB-approved protocol.
- Able to speak, read, and comprehend English fluently.
- Subject is 18 years of age or older.
- Subjects must have sufficient tissue available to fulfill the specimen requirements of the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Curebase Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
Related publications
- Validation of a tissue-based predictive RNA test for immunotherapy benefit in NSCLC: the PREDAPT study.NPJ Precis Oncol · 2026 · PMID 42834100
This page is information, not medical advice. Discuss any trial with your doctor.