Clinical Trial: Utilizing a Multi-gene Testing Approach to Identify Hereditary Pancreatic Cancer

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title: Utilizing a Multi-gene Testing Approach to Identify Hereditary Pancreatic Cancer in Consecutive Cases Unselected for Family History

Brief Summary: The primary objective of the study will be to estimate the prevalence of germline mutations in patients who present consecutively within 12 weeks of a confirmed diagnosis of pancreatic ductal adenocarcinoma.

Detailed Summary: The proposed research is a multi-site prospective and observational plan to investigate the prevalence of germline mutations in patients diagnosed with pancreatic cancer. Thirty two genes will be analyzed, all of which have been associated with an increased risk for cancer. The genes are included on CancerNextTM a multi-gene next generation sequencing and array CGH test. The 32 genes include: APC, ATM, BARD1, BRCA1, BRCA2, BRIP1, BMPR1A, CDH1, CDK4, CDKN2A, CHEK2, EPCAM, GREM1, MLH1, MRE11A, MSH2, MSH6, MUTYH, NBN, NF1, PALB2, PMS2, POLD1, POLE, PTEN, RAD50, RAD51C, RAD51D, SMAD4, SMARCA4, STK11, and TP53 .
Sponsor: Ambry Genetics

Current Primary Outcome: Germline Mutation Prevalence [ Time Frame: 18 months ]

The primary objective of the study will be to estimate the prevalence of germline mutations in patients who present consecutively to the clinical site within 12 weeks of a histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Associate age at diagnosis with germline mutation status and family history [ Time Frame: 18 months ]
  • Access the psychological impact of testing for hereditary pancreatic cancer [ Time Frame: 18 months ]
    A previously validated questionnaire, the Multidimensional Impact of Cancer Risk Assessment (MICRA) will be used as a measure of the psychological impact of genetic testing.


Original Secondary Outcome: Same as current

Information By: Ambry Genetics

Dates:
Date Received: May 25, 2016
Date Started: May 2016
Date Completion: May 2021
Last Updated: August 1, 2016
Last Verified: August 2016