Clinical trial Recruiting at 1 site Observational Ages 18 and up

Collection of tumor samples from cancer patients for diagnostic test development

Official title: Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies

Run by Cofactor Genomics, Inc. · NCT04510129 · Data updated 2026-11-12

This study is collecting tumor samples from cancer patients who are getting certain treatments to help create better tests for managing cancer in the future.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment1650 (estimated)
SponsorCofactor Genomics, Inc.
Industry-sponsored
Drugs / interventionsimmunotherapy
Locations1 site (San Francisco, California)
StatusRecruiting
StartedFebruary 5, 2020
Main results expectedFebruary 2027
Study endsFebruary 2027
Registry record updatedMarch 12, 2025
Trial IDNCT04510129 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients diagnosed with specific cancers such as head and neck cancer, lung cancer, or urothelial carcinoma who are scheduled to receive PD-1/PD-L1 immunotherapy.

Probably not a fit

Patients who have not undergone a pre-treatment tumor biopsy or are not receiving PD-1/PD-L1 immunotherapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect de-identified tumor samples along with clinical and demographic data from patients with various types of cancer who are scheduled for or have recently undergone pre-treatment tumor biopsies. The focus is on patients receiving PD-1/PD-L1 inhibitors, and the study will utilize existing biopsies taken as part of standard care, without requiring additional procedures. The collected specimens and data will be used in future studies to develop and validate diagnostic tests for cancer treatment.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic tests that enhance treatment strategies for cancer patients.

How similar studies have gone: Other studies have successfully utilized similar biospecimen collection approaches to advance cancer diagnostics, indicating a promising avenue for this research.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Subject must have a disease of interest. Specifically, subject must have one of:

   1. head and neck squamous cell carcinoma (HNSCC)
   2. non-small-cell lung cancer (NSCLC)
   3. small cell lung cancer (SCLC)
   4. urothelial carcinoma (UCC)
   5. gastric or gastroesophageal junction adenocarcinoma
   6. cervical cancer
   7. esophageal squamous cell carcinoma (ESCC)
   8. triple-negative breast cancer (TNBC)
   9. hepatocellular carcinoma (HCC)
   10. renal cell carcinoma (RCC)
   11. colorectal cancer (CRC)
2. 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.
3. Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1/PD-L1 immunotherapy.
4. 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.
5. Willing to provide electronic informed consent per IRB-approved protocol.
6. Able to speak, read, and comprehend English fluently.
7. Subject is 18 years of age or older.
8. Subjects must have sufficient tissue available to fulfill the specimen requirements of the study.

Exclusion Criteria:

1. Inability or unwillingness to provide informed consent.
2. Subject who does/did not have one of the cancers listed above (other histologies).
3. Subject has already participated in this trial.

Where it's running

  • Curebase
    San Francisco, California, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.