Decipher Genomics Resource Information Database



Status:Enrolling by invitation
Conditions:Prostate Cancer, Cancer, Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:3/8/2019
Start Date:October 2015

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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.

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
We found this trial at
10
sites
44 Binney St
Boston, Massachusetts 02115
(617) 632-6364
Dana-Farber/Brigham and Women's Cancer Center Boston's Brigham and Women's Hospital (BWH) is an international leader...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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Baltimore, Maryland 21287
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Evanston, IL
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Indian Wells, California 92210
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Philadelphia, PA
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Royal Oak, Michigan 48067
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Royal Oak, MI
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San Francisco, California 94143
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San Francisco, CA
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Tampa, Florida 33612
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Tampa, FL
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