Collection of tumor samples from cancer patients for diagnostic test development

Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies

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 type: Observational
• Enrollment: 1650 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cofactor Genomics, Inc. (industry)
• Drugs / interventions: immunotherapy
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT04510129 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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

Eligibility 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 this trial is running

San Francisco, California

• Curebase — San Francisco, California, United States (RECRUITING)

Study contacts

• Study coordinator: Clinical Trial Coordinator

Conditions: Cancer of Head and Neck, Lung Cancer, Nonsmall Cell, Small-cell Lung Cancer, Urothelial Carcinoma, Gastroesophageal Junction Adenocarcinoma, Cervical Cancer, Esophageal Squamous Cell Carcinoma, Triple Negative Breast Cancer