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Decipher Genomics Resource Information Database (GRID®)

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ClinicalTrials.gov Identifier: NCT02609269
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
GenomeDx Biosciences Corp

November 16, 2015
November 20, 2015
June 12, 2017
October 2015
December 2020   (Final data collection date for primary outcome measure)
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
Link complete genomic expression array generated from Decipher testing with the longitudinal clinical data for patients who consent to participate in the Decipher GRID registry. [ Time Frame: Through study completion, an average of 1 year ]
Registry will be used for evaluation in ongoing research into the role of biomarkers in the biology of certain cancers.
Complete list of historical versions of study NCT02609269 on ClinicalTrials.gov Archive Site
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Not Provided
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Decipher Genomics Resource Information Database
Prospective Expression Analysis Using The Decipher Genomics Resource Information Database (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.
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.
Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
1 Year
Not Provided
Non-Probability Sample
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.
Prostate Cancer
  • 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
Decipher GRID Patients
Patients who have been tested with any of the Decipher suite of genomic solutions.
Interventions:
  • Other: Decipher Prostate Cancer Classifier
  • Other: Decipher Genomics Resource Information Database (GRID)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10000
500
Not Provided
December 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
Child, Adult, Older Adult
No
Contact: Jill Collins, PhD 1-858-322-6161 jill.collins@genomedx.com
United States
 
 
NCT02609269
GRD001
No
Not Provided
Not Provided
GenomeDx Biosciences Corp
GenomeDx Biosciences Corp
Not Provided
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
GenomeDx Biosciences Corp
June 2017