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NCT04510129 | RECRUITING | Cancer of Head and Neck

A Multicenter Cancer Biospecimen Collection Study
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.

Condition or disease

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

Intervention/treatment

OncoPrism™ assay

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 Type : OBSERVATIONAL
Estimated Enrollment : 1650 participants
Official Title : Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies
Actual Study Start Date : 2020-02-05
Estimated Primary Completion Date : 2027-02
Estimated Study Completion Date : 2027-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
A Multicenter Cancer Biospecimen Collection Study

Location Details

NCT04510129

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Curebase

San Francisco, California, United States, 94131