RecruitingNCT04510129

A Multicenter Cancer Biospecimen Collection Study

Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies

Sponsor

Cofactor Genomics, Inc.

Enrollment

1,650 participants

Start Date

Feb 5, 2020

Study Type

OBSERVATIONAL

Conditions

Cancer of Head and Neck Lung Cancer, Nonsmall Cell

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria19

Subject must have a disease of interest. Specifically, subject must have one of:
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)
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.
Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1/PD-L1 immunotherapy.
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.
Willing to provide electronic informed consent per IRB-approved protocol.
Able to speak, read, and comprehend English fluently.
Subject is 18 years of age or older.
Subjects must have sufficient tissue available to fulfill the specimen requirements of the study.

Exclusion Criteria3

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

Interventions

DIAGNOSTIC_TESTOncoPrism™ assay

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

Locations(1)

Curebase

San Francisco, California, United States

View Full Details on ClinicalTrials.gov

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NCT04510129

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