Recruiting
A Multicenter Cancer Biospecimen Collection Study
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.
ClinicalTrials.gov IDNCT04510129
PhaseNot Applicable
Enrollment1650
SponsorCofactor Genomics, Inc.
Age18 Years
SexALL
Conditions studied
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, Hepatocellular Carcinoma, Renal Cell Carcinoma, Colorectal Cancer
About this study
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.
Interventions
- Diagnostic Test: OncoPrism™ assay — OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
Primary outcomes
- PD-L1/PD-1 inhibitor response (6 months)
Eligibility information
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.
Study locations
- Curebase, San Francisco, California 94131 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.