Utilizing A Multi-gene Testing Approach To Identify Hereditary Pancreatic Cancer

Study Overview

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

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.

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 .

Pancreatic Ductal Adenocarcinoma

GENETIC: Multi-gene Next Generation Sequencing Panel

NEX_14_028

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-05-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-08-24
First Submitted that Met QC Criteria 2016-06-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-08-25
First Posted (ACTUAL) 2016-06-06	Results First Posted N/A	Last Verified 2020-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Germline Mutation Prevalence	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.	18 months

Secondary Outcome Measures	Measure Description	Time Frame
Associate age at diagnosis with germline mutation status and family history		18 months
Access the psychological impact of testing for hereditary pancreatic cancer	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.	18 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Beth Israel Deaconess Medical Center
University of Pittsburgh Medical Center
HonorHealth Research Institute

Investigators

PRINCIPAL_INVESTIGATOR: Randall Brand, MD, University of Pittsburgh

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Cella D, Hughes C, Peterman A, Chang CH, Peshkin BN, Schwartz MD, Wenzel L, Lemke A, Marcus AC, Lerman C. A brief assessment of concerns associated with genetic testing for cancer: the Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire. Health Psychol. 2002 Nov;21(6):564-72.

Learn

Resources

PatientS

Caregivers

Clinical Trial Record