A Multicenter Cancer Biospecimen Collection Study

Recruiting

• Conditions: Triple Negative Breast Cancer; Small-cell Lung Cancer; Esophageal Squamous Cell Carcinoma; Renal Cell Carcinoma; Urothelial Carcinoma; Gastroesophageal Junction Adenocarcinoma; Hepatocellular Carcinoma; Cancer of Head and Neck; Lung Cancer, Nonsmall Cell; Cervical Cancer
• Interventions: Diagnostic Test: OncoPrism™ assay

• Registration Number: NCT04510129
• Lead Sponsor: Cofactor Genomics, Inc.

Brief Summary

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.

Detailed Description

This study will establish a prospective cohort of pre-treatment tumor specimens with correlated de-identified clinical and demographic data and tissue histology from cancer patients who are undergoing treatment with PD-1/PD-L1 inhibitors. Patients who have undergone pre-anti-PD-1/PD-L1-treatment tumor biopsy or who are scheduled for tumor biopsy prior to anti-PD-1/PD-L1 treatment will be enrolled.

The study will not require a study-specific tumor biopsy; any biopsies taken prior to treatment as part of standard of care are eligible for this study. Biopsies must not have been taken after immunotherapy treatment began.

Participants will be asked to provide their consent for the potential use of their biospecimens in subsequent studies for the development and validation of a diagnostic test.

Study Timeline

• Study Start: 2020-02-05
• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1650

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-small-cell lung cancer (NSCLC)	OncoPrism™ assay	-
cervical cancer	OncoPrism™ assay	-
triple-negative breast cancer (TNBC)	OncoPrism™ assay	-
head and neck squamous cell carcinoma (HNSCC)	OncoPrism™ assay	-
urothelial carcinoma (UCC)	OncoPrism™ assay	-
esophageal squamous cell carcinoma (ESCC)	OncoPrism™ assay	-
renal cell carcinoma (RCC)	OncoPrism™ assay	-
colorectal cancer (CRC)	OncoPrism™ assay	-
gastric or gastroesophageal junction adenocarcinoma	OncoPrism™ assay	-
small cell lung cancer (SCLC)	OncoPrism™ assay	-
hepatocellular carcinoma (HCC)	OncoPrism™ assay	-

Primary Outcome Measures

Name	Time	Method
PD-L1/PD-1 inhibitor response	6 months	No response to treatment with PD-L1/PD-1 inhibitor and response to treatment with PD-L1/PD-1 inhibitor.

Trial Locations

Locations (1)

Curebase; 🇺🇸 San Francisco, California, United States