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. |
ClinicalTrials.gov Identifier: NCT02609269 |
Recruitment Status :
Enrolling by invitation
First Posted : November 20, 2015
Last Update Posted : March 6, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Prostate Cancer | Other: Decipher Prostate Cancer Classifier Other: Decipher Genomics Resource Information Database (GRID) |
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 |

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 |
- 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

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.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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:
-
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
- Low risk: T1-T2a, Gleason score ≤ 6, PSA < 10ng/mL
- Intermediate risk: T2b-T2c, Gleason score 7, or PSA 10-20 ng/mL
- High risk: T3a, or Gleason score 8-10, or PSA > 20 ng/mL
Exclusion Criteria:
- Diagnosed with metastatic disease (M1)
- Metastatic Disease (M+) prior to surgery
- For salvage setting patients: Metastatic Disease (M+) at PSA rise
- Received any neo-adjuvant prostate cancer treatment before radical prostatectomy
- Required patient clinical data is not available for evaluation of eligibility criteria
- Any other medical condition that the treating physician,study investigators or designee determines should exclude the subject from the study

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 ClinicalTrials.gov identifier (NCT number): NCT02609269
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 |
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 |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | GenomeDx Biosciences Corp |
ClinicalTrials.gov 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 |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |