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Decipher Genomics Resource Information Database (GRID®)

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ClinicalTrials.gov Identifier: NCT02609269
Recruitment Status : Enrolling by invitation
First Posted : November 20, 2015
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
GenomeDx Biosciences Corp

Tracking Information
First Submitted Date November 16, 2015
First Posted Date November 20, 2015
Last Update Posted Date March 6, 2019
Study Start Date October 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 5, 2016)
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
Original Primary Outcome Measures
 (submitted: November 18, 2015)
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.
Change History Complete list of historical versions of study NCT02609269 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Decipher Genomics Resource Information Database
Official Title Prospective Expression Analysis Using The Decipher Genomics Resource Information Database (GRID)® and Data Sharing Program
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.
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
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.
Condition Prostate Cancer
Intervention
  • 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
Study Groups/Cohorts 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: November 24, 2015)
10000
Original Estimated Enrollment
 (submitted: November 18, 2015)
500
Study Completion Date Not Provided
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02609269
Other Study ID Numbers GRD001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GenomeDx Biosciences Corp
Study Sponsor GenomeDx Biosciences Corp
Collaborators Not Provided
Investigators
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
PRS Account GenomeDx Biosciences Corp
Verification Date March 2019