A Multicenter Cancer Biospecimen Collection Study


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Trial ID: NCT04510129


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.

Official Title

Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies

Stanford Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)


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.


diagnostic test: OncoPrism™ assay


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Steven Tai Lai

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