A Multicenter Cancer Biospecimen Collection Study

Sponsor

Cofactor Genomics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04510129

Collaborator

Curebase, Inc. (Other)

1,650

Enrollment

Location

35.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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	Diagnostic Test: 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 Design

Study Type:

Observational

Anticipated Enrollment :

1650 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies

Actual Study Start Date :

Feb 5, 2020

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
head and neck squamous cell carcinoma (HNSCC)	Diagnostic Test: OncoPrism™ assay OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
non-small-cell lung cancer (NSCLC)	Diagnostic Test: OncoPrism™ assay OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
small cell lung cancer (SCLC)	Diagnostic Test: OncoPrism™ assay OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
urothelial carcinoma (UCC)	Diagnostic Test: OncoPrism™ assay OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
gastric or gastroesophageal junction adenocarcinoma	Diagnostic Test: OncoPrism™ assay OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
cervical cancer	Diagnostic Test: OncoPrism™ assay OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
esophageal squamous cell carcinoma (ESCC)	Diagnostic Test: OncoPrism™ assay OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
triple-negative breast cancer (TNBC)	Diagnostic Test: OncoPrism™ assay OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
hepatocellular carcinoma (HCC)	Diagnostic Test: OncoPrism™ assay OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
renal cell carcinoma (RCC)	Diagnostic Test: OncoPrism™ assay OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
colorectal cancer (CRC)	Diagnostic Test: OncoPrism™ assay OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

Outcome Measures

Primary Outcome Measures

PD-L1/PD-1 inhibitor response [6 months]
No response to treatment with PD-L1/PD-1 inhibitor and response to treatment with PD-L1/PD-1 inhibitor.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.