A Multicenter Cancer Biospecimen Collection Study

Last updated: March 10, 2025
Sponsor: Cofactor Genomics, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Vaginal Cancer

Colon Cancer

Treatment

OncoPrism™ assay

Clinical Study ID

NCT04510129
PREDAPT
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Subject must have a disease of interest. Specifically, subject must have one of:

  2. head and neck squamous cell carcinoma (HNSCC)

  3. non-small-cell lung cancer (NSCLC)

  4. small cell lung cancer (SCLC)

  5. urothelial carcinoma (UCC)

  6. gastric or gastroesophageal junction adenocarcinoma

  7. cervical cancer

  8. esophageal squamous cell carcinoma (ESCC)

  9. triple-negative breast cancer (TNBC)

  10. hepatocellular carcinoma (HCC)

  11. renal cell carcinoma (RCC)

  12. colorectal cancer (CRC)

  13. Subject must have received, or be scheduled to receive, at least one dose ofanti-PD-1/PD-L1 immunotherapy for treatment of their cancer.

  14. Subject must have had, or will have, a tumor biopsy prior to treatment withanti-PD-1/PD-L1 immunotherapy.

  15. Subject must have undergone, or will undergo, medical imaging (e.g. CT or MRI) ofthe tumor prior to treatment with anti-PD-1/PD-L1 immunotherapy.

  16. Willing to provide electronic informed consent per IRB-approved protocol.

  17. Able to speak, read, and comprehend English fluently.

  18. Subject is 18 years of age or older.

  19. Subjects must have sufficient tissue available to fulfill the specimen requirementsof the study.

Exclusion

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

Total Participants: 1650
Treatment Group(s): 1
Primary Treatment: OncoPrism™ assay
Phase:
Study Start date:
February 05, 2020
Estimated Completion Date:
February 28, 2027

Study 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.

Connect with a study center

  • Curebase

    San Francisco, California 94131
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.