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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-04

Study Completion Date

2020-08-15

Brief Summary

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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.

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Detailed Description

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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 .

Conditions

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Pancreatic Ductal Adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Multi-gene Next Generation Sequencing Panel

Participants will have genetic testing

Intervention Type GENETIC

Other Intervention Names

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CancerNext

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No