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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02790944
Recruitment Status : Completed
First Posted : June 6, 2016
Last Update Posted : August 25, 2020
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
University of Pittsburgh Medical Center
HonorHealth Research Institute
Information provided by (Responsible Party):
Ambry Genetics

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.

Condition or disease Intervention/treatment
Pancreatic Ductal Adenocarcinoma Genetic: Multi-gene Next Generation Sequencing Panel

Detailed Description:
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 .

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utilizing a Multi-gene Testing Approach to Identify Hereditary Pancreatic Cancer in Consecutive Cases Unselected for Family History
Actual Study Start Date : May 4, 2016
Actual Primary Completion Date : August 15, 2020
Actual Study Completion Date : August 15, 2020



Intervention Details:
  • Genetic: Multi-gene Next Generation Sequencing Panel
    Participants will have genetic testing
    Other Name: CancerNext


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Associate age at diagnosis with germline mutation status and family history [ Time Frame: 18 months ]
  2. 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.


Biospecimen Retention:   Samples With DNA
Blood, saliva or DNA


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be patients who are diagnosed within 12 weeks of enrollment with Pancreatic Ductal Adenocarcinoma.
Criteria

Inclusion Criteria:

  • Male and female patients between the ages of 18 and 89 years of age.
  • Diagnosed within the previous 12 weeks with histologically or cytologically confirmed PDAC Stage I to IV.
  • Ability of participant to understand and the willingness to sign a written informed consent document.
  • Participant must agree to sample collection and genetic testing using the 32 gene test, CancerNextTM and allow the test result to be part of their medical record.

Exclusion Criteria:

  • Diagnosed with intraductal papillary mucinous neoplasms, mucinous cystic neoplasms, pancreatic neuroendocrine tumors or dysplasia without PDAC.
  • Diagnosed with PDAC more than 12 weeks before presenting to the clinical site.
  • Patients meeting the above enrollment criteria who have had CancerNext performed previously.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790944


Locations
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United States, Arizona
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215-5400
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Ambry Genetics
Beth Israel Deaconess Medical Center
University of Pittsburgh Medical Center
HonorHealth Research Institute
Investigators
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Principal Investigator: Randall Brand, MD University of Pittsburgh
Principal Investigator: Nadine Tung, MD Beth Israel Deaconess
Principal Investigator: Erkut Borazanci, MD HonorHealth Research Institute
Publications:
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Responsible Party: Ambry Genetics
ClinicalTrials.gov Identifier: NCT02790944    
Other Study ID Numbers: NEX_14_028
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ambry Genetics:
Germline
Pancreatic
Genetic Testing