Decipher Genomics Resource for Intelligent Discovery

Официальное название

Prospective Expression Analysis Using The Decipher Genomics Resource for Intelligent Discovery (GRID)® and Data Sharing Program

Обзор

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.

Подробное описание

Observational study involving the release of tumor genome-wide expression data generated by the Decipher assay which will be linked to clinical treatment and outcome data for patients in whom Decipher clinical testing was performed. The GRID database population will be used to characterize the genomics of cancer and discover or validate gene expression signatures that may be useful for understanding of the biology of the disease and implementing precision medicine approaches for cancer patients.

Вмешательства

• Другое Decipher Cancer Classifier
  The Decipher are gene expression-based tests that are used to better risk stratify or characterize tumor biology that are commercially available through Veracyte, Inc CLIA \& CAP certified laboratory in San Diego, CA

Первичные конечные точки

• Link complete genomic RNA expression array data generated from Decipher testing with clinical data for patients who consent to participate. [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

Subjects that have had a Decipher clinical test

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. do PMID 23770138
• 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. PMID 26058959
• 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. PMID 24998118
• 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. PMID 25667284
• 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 PMID 25035207
• 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.p PMID 23826159
• Jairath NK, Dal Pra A, Vince R Jr, Dess RT, Jackson WC, Tosoian JJ, McBride SM, Zhao SG, Berlin A, Mahal BA, Kishan AU, Den RB, Freedland SJ, Salami SS, Kaffenberger SD, Pollack A, Tran P, Mehra R, Morgan TM, Weiner AB, Mohamad O, Carroll PR, Cooperberg MR, Karnes RJ, Nguyen PL, Michalski JM, Tward JD, Feng FY, Schaeffer EM, Spratt DE. A Systematic Review of the Evidence for the Decipher Genomic C PMID 33293078
• Qiu X, Boufaied N, Hallal T, Feit A, de Polo A, Luoma AM, Alahmadi W, Larocque J, Zadra G, Xie Y, Gu S, Tang Q, Zhang Y, Syamala S, Seo JH, Bell C, O'Connor E, Liu Y, Schaeffer EM, Jeffrey Karnes R, Weinmann S, Davicioni E, Morrissey C, Cejas P, Ellis L, Loda M, Wucherpfennig KW, Pomerantz MM, Spratt DE, Corey E, Freedman ML, Shirley Liu X, Brown M, Long HW, Labbe DP. MYC drives aggressive prostat PMID 35562350

Идентификаторы

NCT: NCT02609269 · GRD001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗