Decipher Genomics Resource for Intelligent Discovery (GRID®)

February 15, 2023 updated by: GenomeDx Biosciences Corp

Prospective Expression Analysis Using The Decipher Genomics Resource for Intelligent Discovery (GRID)® and Data Sharing Program

To prospectively evaluate the utility of genomic expression data as a tool to better characterize the tumors of individual patients, and to understand how genomic information from individual patients undergoing routine clinical testing can be used in population-level analysis to improve treatment and outcomes.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Observational study involving the release of tumor genome-wide expression data generated by the Decipher assay which will be linked to clinical treatment and outcome data for patients in whom Decipher clinical testing was performed. The GRID database population will be used to characterize the genomics of cancer and discover or validate gene expression signatures that may be useful for understanding of the biology of the disease and implementing precision medicine approaches for cancer patients.

Study Type

Observational

Enrollment (Anticipated)

1000000

Contacts and Locations

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

Study Locations

  • United States
    • California
      • Indian Wells, California, United States, 92210
        • Desert Medical Imaging LLC
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • San Francisco, California, United States, 94158
        • University of California San Francisco
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Northwestern University Feinberg School of Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber/Brigham and Women's Cancer Center
    • Michigan
      • Royal Oak, Michigan, United States, 48067
        • Comprehensive Urology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Sidney Kimmel Medical College at Thomas Jefferson University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing Decipher testing in the clinical setting. It is understood that the Decipher test results may be used as a part of normal clinical care. Any patient meeting the following criteria who has been tested with Decipher can participate in the study.

Description

Inclusion Criteria:

Subjects that have had a Decipher clinical test

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
Decipher GRID Patients
Patients who have been tested with any of the Decipher clinical tests
Other: Decipher Cancer Classifier
The Decipher are gene expression-based tests that are used to better risk stratify or characterize tumor biology that are commercially available through Veracyte, Inc CLIA & CAP certified laboratory in San Diego, CA
Other Names:
  • Decipher Biopsy, Decipher RP, Decipher Bladder, Decipher Renal, Decipher Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Link complete genomic RNA expression array data generated from Decipher testing with clinical data for patients who consent to participate.
Time Frame: Through study completion, an average of 1 year
Role of genomic expression data in the biology of certain cancers
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

GenomeDx Biosciences Corp

Collaborators

Veracyte, Inc.

Investigators

  • Principal Investigator: Elai Davicioni, PhD, Veracyte, Inc.

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.

General Publications

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)

October 1, 2015

Primary Completion (Anticipated)

December 1, 2030

Study Completion (Anticipated)

December 1, 2040

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 18, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRD001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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