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RecruitingNCT04510129

A Multicenter Cancer Biospecimen Collection Study

Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies

Status
Recruiting
Phase
—
Study type
Observational
Enrollment
1,650 (estimated)
Sponsor
Cofactor Genomics, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTOncoPrism™ assayOncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

Timeline

Start date
2020-02-05
Primary completion
2027-02-01
Completion
2027-02-01
First posted
2020-08-12
Last updated
2025-03-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04510129. Inclusion in this directory is not an endorsement.