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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cofactor Genomics, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Curebase Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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