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Eligibility
for males
Location
at San Francisco, California and other locations
Dates
study started

Description

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.

Official Title

Prospective Expression Analysis Using The Decipher Genomics Resource Information Database (GRID)® and Data Sharing Program

Details

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.

Keywords

Prostate Cancer

Eligibility

You can join if…

Open to males

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

    1. Low risk: T1-T2a, Gleason score ≤ 6, PSA < 10ng/mL
    2. Intermediate risk: T2b-T2c, Gleason score 7, or PSA 10-20 ng/mL
    3. High risk: T3a, or Gleason score 8-10, or PSA> 20 ng/mL

You CAN'T join if...

  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

Locations

  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles, California, 90048, United States
  • Desert Medical Imaging LLC accepting new patients
    Indian Wells, California, 92210, United States

Details

Status
accepting new patients
Start Date
Sponsor
GenomeDx Biosciences Corp
Links
Website for GenomeDx Biosciences (study sponsor)
ID
NCT02609269
Study Type
Observational [Patient Registry]
Last Updated
June 1, 2017
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