A Multicenter Cancer Biospecimen Collection Study

Cofactor Genomics

Status: Enrolling

Conditions: Lung Cancer, Nonsmall Cell; Small-cell Lung Cancer; Cancer of Head and Neck; Urothelial Carcinoma; Hepatocellular Carcinoma; Esophageal Squamous Cell Carcinoma; Renal Cell Carcinoma; Triple Negative Breast Cancer; Gastroesophageal Junction Adenocarcinoma; Cervical Cancer; Colorectal Cancer

Treatments: Diagnostic Test: OncoPrism™ assay

Study type: Observational

Funder types: Industry

Identifiers

NCT04510129

PREDAPT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,650 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,650 participants in 11 patient groups

head and neck squamous cell carcinoma (HNSCC)

Treatment:

Diagnostic Test: OncoPrism™ assay

non-small-cell lung cancer (NSCLC)

Treatment:

Diagnostic Test: OncoPrism™ assay

small cell lung cancer (SCLC)

Treatment:

Diagnostic Test: OncoPrism™ assay

urothelial carcinoma (UCC)

Treatment:

Diagnostic Test: OncoPrism™ assay

gastric or gastroesophageal junction adenocarcinoma

Treatment:

Diagnostic Test: OncoPrism™ assay

cervical cancer

Treatment:

Diagnostic Test: OncoPrism™ assay

esophageal squamous cell carcinoma (ESCC)

Treatment:

Diagnostic Test: OncoPrism™ assay

triple-negative breast cancer (TNBC)

Treatment:

Diagnostic Test: OncoPrism™ assay

hepatocellular carcinoma (HCC)

Treatment:

Diagnostic Test: OncoPrism™ assay

renal cell carcinoma (RCC)

Treatment:

Diagnostic Test: OncoPrism™ assay

colorectal cancer (CRC)

Treatment:

Diagnostic Test: OncoPrism™ assay