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Decipher Genomics Resource Information Database (GRID®)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02609269
Recruitment Status : Unknown
Verified March 2019 by GenomeDx Biosciences Corp.
Recruitment status was:  Enrolling by invitation
First Posted : November 20, 2015
Last Update Posted : March 6, 2019
Information provided by (Responsible Party):
GenomeDx Biosciences Corp

Brief Summary:
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.

Condition or disease Intervention/treatment
Prostate Cancer Other: Decipher Prostate Cancer Classifier Other: Decipher Genomics Resource Information Database (GRID)

Detailed Description:
Observational study involving the release of genome-wide expression data allowing participating institutions to pair these data with clinical treatment and outcome data for patients in whom Decipher testing was performed. Through these collaborations, the GRID database population will be used to characterize the genomics of cancer and discover new gene expression signatures that may be useful for expanding the current understanding of the biology of the disease.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Prospective Expression Analysis Using The Decipher Genomics Resource Information Database (GRID)® and Data Sharing Program
Study Start Date : October 2015
Estimated Primary Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Decipher GRID Patients
Patients who have been tested with any of the Decipher suite of genomic solutions.
Other: Decipher Prostate Cancer Classifier
The Decipher Prostate Cancer Classifier (Decipher Test) is a genomic test that predicts the probability of high-grade disease, metastasis and prostate cancer specific mortality for men with prostate cancer and is commercially available through GenomeDx Biosciences' CLIA & CAP certified laboratory in San Diego, CA
Other Name: Decipher Biopsy, Decipher Post-Op, Decipher Test

Other: Decipher Genomics Resource Information Database (GRID)
The Decipher GRID (GRID) is the world's largest research use only (RUO), clinically annotated urologic cancer genomic expression database, built up over 8 years of US and international research conducted using the Decipher® (Decipher) test platform. The GRID currently consists of genomic data comprised of 1.4M data points per patient from more than 20,000 prostate and bladder cancer patients, including those from published retrospective clinical studies that have been annotated with comprehensive treatment and outcomes data. It is anticipated that the GRID will also contain data from several other types of cancer in the future.
Other Name: Decipher GRID

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

Decipher Post-Op Clinical Indications

  • Patient must have achieved initial PSA nadir (defined as undetectable PSA of

    ≤0.1 ng/mL) within 4-6 weeks, and

  • Pathological stage T2 disease with a positive surgical margin, or
  • Pathological stage T3 disease (e.g., extraprostatic extension, seminal vesicle invasion, bladder neck invasion), or
  • High Preoperative PSA (e.g., PSA ≥20 ng/mL), or
  • High Gleason grade disease (e.g., Gleason 7 to 10 or Tertiary Gleason pattern 5), or
  • Perineural, lymphovascular invasion, or
  • Lymph node involvement, or
  • Rising PSA or Biochemical Recurrence

Decipher Biopsy Clinical Indications

• Any patient diagnosed with localized prostate cancer and assessed as being very low, low, intermediate or high risk by NCCN guidelines:

  1. Very low risk: T1c, Gleason score ≤ 6, PSA < 10ng/mL, fewer than 3 prostate biopsy cores positive,

    • 50% cancer in any core, PSA density <0.15 ng/mL/g
  2. Low risk: T1-T2a, Gleason score ≤ 6, PSA < 10ng/mL
  3. Intermediate risk: T2b-T2c, Gleason score 7, or PSA 10-20 ng/mL
  4. High risk: T3a, or Gleason score 8-10, or PSA > 20 ng/mL

Exclusion Criteria:

  1. Diagnosed with metastatic disease (M1)
  2. Metastatic Disease (M+) prior to surgery
  3. For salvage setting patients: Metastatic Disease (M+) at PSA rise
  4. Received any neo-adjuvant prostate cancer treatment before radical prostatectomy
  5. Required patient clinical data is not available for evaluation of eligibility criteria
  6. Any other medical condition that the treating physician,study investigators or designee determines should exclude the subject from the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02609269

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United States, California
Desert Medical Imaging LLC
Indian Wells, California, United States, 92210
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of California San Francisco
San Francisco, California, United States, 94158
United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Illinois
Northwestern University Feinberg School of Medicine
Evanston, Illinois, United States, 60208
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States, 02115
United States, Michigan
Comprehensive Urology
Royal Oak, Michigan, United States, 48067
United States, Pennsylvania
Sidney Kimmel Medical College at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
GenomeDx Biosciences Corp
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Principal Investigator: Elai Davicioni, Ph.D. President & Chief Scientific Officer, GenomeDx Biosciences
Principal Investigator: Tim Triche, M.D., Ph.D. Laboratory Medical Director and Chairman, GenomeDx Biosciences
Additional Information:
Choeurng, V. et al., Recalibration of Genomic Risk Prediction Models in Prostate Cancer to Improve Individual-Level Predictions. JSM 2015 Abstract.
Den, R. et al., Validation of a Genomic Classifier for Prediction of Metastasis following Postoperative Salvage Radiation Therapy. J Clin Oncol 33, 2015 (suppl; abstr 5016).

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: GenomeDx Biosciences Corp Identifier: NCT02609269    
Other Study ID Numbers: GRD001
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases