A Multicenter Cancer Biospecimen Collection Study

March 10, 2025 updated by: Cofactor Genomics, Inc.

Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

1650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PD-L1/PD-1 inhibitor response
Time Frame: 6 months
No response to treatment with PD-L1/PD-1 inhibitor and response to treatment with PD-L1/PD-1 inhibitor.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cofactor Genomics, Inc.

Collaborators

Curebase Inc.

Investigators

  • Study Director: Jarret Glasscock, Cofactor Genomics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2020

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREDAPT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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