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Decipher Genomics Resource Information Database (GRID®)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by GenomeDx Biosciences Corp
Sponsor:
Information provided by (Responsible Party):
GenomeDx Biosciences Corp
ClinicalTrials.gov Identifier:
NCT02609269
First received: November 16, 2015
Last updated: December 5, 2016
Last verified: December 2016
  Purpose
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 Intervention
Prostate Cancer
Other: Decipher Prostate Cancer Classifier
Other: Decipher Genomics Resource Information Database (GRID)

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GenomeDx Biosciences Corp:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 10000
Study Start Date: October 2015
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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.
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02609269

Contacts
Contact: Allison Porreco Levesque 1-858-252-1782 ext 188 allison.levesque@genomedx.com

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Hyung L. Kim, MD         
University of California San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Peter Carroll, MD, MPH         
United States, Florida
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Sanoj Punnen, MD         
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Kosj Yamoah, MD, PhD         
United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Evanston, Illinois, United States, 60208
Contact: Edward M Schaeffer, MD, PhD         
United States, Maryland
Johns Hopkins School of Medicine Recruiting
Baltimore, Maryland, United States, 21287
Contact: Ashley Ross, MD, PhD         
United States, Massachusetts
Dana Farber/Brigham and Women's Cancer Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Paul L. Nguyen, MD         
United States, Michigan
Comprehensive Urology Recruiting
Royal Oak, Michigan, United States, 48067
Contact: Frankie Mullins, RN         
United States, Pennsylvania
Sidney Kimmel Medical College at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Adam P. Dicker, MD, PhD         
Sponsors and Collaborators
GenomeDx Biosciences Corp
Investigators
Principal Investigator: Elai Davicioni, Ph.D. President & Chief Scientific Officer, GenomeDx Biosciences
Principal Investigator: Tim Triche, M.D., Ph.D. aboratory Medical Director and Chairman, GenomeDx Biosciences
  More Information

Additional Information:
Publications:
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).

Responsible Party: GenomeDx Biosciences Corp
ClinicalTrials.gov Identifier: NCT02609269     History of Changes
Other Study ID Numbers: GRD001
Study First Received: November 16, 2015
Last Updated: December 5, 2016

ClinicalTrials.gov processed this record on April 28, 2017