Decipher Genomics Resource Information Database (GRID®)

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

Study Description

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.

Condition or disease	Intervention/treatment
Prostate Cancer	Other: Decipher Prostate Cancer Classifier; Other: Decipher Genomics Resource Information Database (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.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 10000 participants
• 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
• Study Start Date: October 2015
• Estimated Primary Completion Date: December 2020

Groups and Cohorts

Group/Cohort

Intervention/treatment

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

Outcome Measures

Primary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• 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

Locations

United States, California

Desert Medical Imaging LLC

Indian Wells, California, United States, 92210

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

University of California San Francisco

San Francisco, California, United States, 94158

United States, Florida

University of Miami Miller School of Medicine

Miami, Florida, United States, 33136

Moffitt Cancer Center

Tampa, Florida, United States, 33612

United States, Illinois

Northwestern University Feinberg School of Medicine

Evanston, Illinois, United States, 60208

United States, Maryland

Johns Hopkins School of Medicine

Baltimore, Maryland, United States, 21287

United States, Massachusetts

Dana Farber/Brigham and Women's Cancer Center

Boston, Massachusetts, United States, 02115

United States, Michigan

Comprehensive Urology

Royal Oak, Michigan, United States, 48067

United States, Pennsylvania

Sidney Kimmel Medical College at Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

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.; Laboratory Medical Director and Chairman, GenomeDx Biosciences

More Information

Additional Information:

Website for Decipher GRID  Website for GenomeDx Biosciences (study sponsor) 

Publications:

Karnes RJ, Bergstralh EJ, Davicioni E, Ghadessi M, Buerki C, Mitra AP, Crisan A, Erho N, Vergara IA, Lam LL, Carlson R, Thompson DJ, Haddad Z, Zimmermann B, Sierocinski T, Triche TJ, Kollmeyer T, Ballman KV, Black PC, Klee GG, Jenkins RB. Validation of a genomic classifier that predicts metastasis following radical prostatectomy in an at risk patient population. J Urol. 2013 Dec;190(6):2047-53. doi: 10.1016/j.juro.2013.06.017. Epub 2013 Jun 11.

Ross AE, Johnson MH, Yousefi K, Davicioni E, Netto GJ, Marchionni L, Fedor HL, Glavaris S, Choeurng V, Buerki C, Erho N, Lam LL, Humphreys EB, Faraj S, Bezerra SM, Han M, Partin AW, Trock BJ, Schaeffer EM. Tissue-based Genomics Augments Post-prostatectomy Risk Stratification in a Natural History Cohort of Intermediate- and High-Risk Men. Eur Urol. 2016 Jan;69(1):157-65. doi: 10.1016/j.eururo.2015.05.042. Epub 2015 Jun 6.

Cooperberg MR, Davicioni E, Crisan A, Jenkins RB, Ghadessi M, Karnes RJ. Combined value of validated clinical and genomic risk stratification tools for predicting prostate cancer mortality in a high-risk prostatectomy cohort. Eur Urol. 2015 Feb;67(2):326-33. doi: 10.1016/j.eururo.2014.05.039. Epub 2014 Jul 2.

Den RB, Yousefi K, Trabulsi EJ, Abdollah F, Choeurng V, Feng FY, Dicker AP, Lallas CD, Gomella LG, Davicioni E, Karnes RJ. Genomic classifier identifies men with adverse pathology after radical prostatectomy who benefit from adjuvant radiation therapy. J Clin Oncol. 2015 Mar 10;33(8):944-51. doi: 10.1200/JCO.2014.59.0026. Epub 2015 Feb 9. Erratum in: J Clin Oncol. 2015 Apr 20;33(12):1416.

Den RB, Feng FY, Showalter TN, Mishra MV, Trabulsi EJ, Lallas CD, Gomella LG, Kelly WK, Birbe RC, McCue PA, Ghadessi M, Yousefi K, Davicioni E, Knudsen KE, Dicker AP. Genomic prostate cancer classifier predicts biochemical failure and metastases in patients after postoperative radiation therapy. Int J Radiat Oncol Biol Phys. 2014 Aug 1;89(5):1038-1046. doi: 10.1016/j.ijrobp.2014.04.052. Epub 2014 Jul 8.

Erho N, Crisan A, Vergara IA, Mitra AP, Ghadessi M, Buerki C, Bergstralh EJ, Kollmeyer T, Fink S, Haddad Z, Zimmermann B, Sierocinski T, Ballman KV, Triche TJ, Black PC, Karnes RJ, Klee G, Davicioni E, Jenkins RB. Discovery and validation of a prostate cancer genomic classifier that predicts early metastasis following radical prostatectomy. PLoS One. 2013 Jun 24;8(6):e66855. doi: 10.1371/journal.pone.0066855. Print 2013.

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).

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Berglund AE, Rounbehler RJ, Gerke T, Awasthi S, Cheng CH, Takhar M, Davicioni E, Alshalalfa M, Erho N, Klein EA, Freedland SJ, Ross AE, Schaeffer EM, Trock BJ, Den RB, Cleveland JL, Park JY, Dhillon J, Yamoah K. Distinct transcriptional repertoire of the androgen receptor in ETS fusion-negative prostate cancer. Prostate Cancer Prostatic Dis. 2019 May;22(2):292-302. doi: 10.1038/s41391-018-0103-4. Epub 2018 Oct 26.

• Responsible Party: GenomeDx Biosciences Corp
• ClinicalTrials.gov Identifier: NCT02609269 History of Changes
• Other Study ID Numbers: GRD001
• First Posted: November 20, 2015
• Last Update Posted: March 6, 2019
• Last Verified: March 2019

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases