Recruiting

Observational Study

Sponsor:

Cofactor Genomics, Inc.

Code:

NCT04510129

Conditions

Cancer of Head and Neck

Lung Cancer, Nonsmall Cell

Small-cell Lung Cancer

Urothelial Carcinoma

Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

OncoPrism™ assay

Study Details

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.

Conditions

Cancer of Head and Neck

Lung Cancer, Nonsmall Cell

Small-cell Lung Cancer

Urothelial Carcinoma

Gastroesophageal Junction Adenocarcinoma

Study ID

NCT04510129

Start date

Feb 5, 2020

Status verified date

Mar, 2025

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1650 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Interventions

OncoPrism™ assay

OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

Primary outcome measure

  • PD-L1/PD-1 inhibitor response [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Curebase

Recruiting

San Francisco, California, United States, 94131

Contacts

More Information

Sponsor

Cofactor Genomics, Inc.

Last update posted

Mar 12, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cofactor Genomics, Inc. on 2025-03-12.