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

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02790944
• Other study ID #: NEX_14_028
• Status: Completed
• Start date: May 4, 2016
• Est. completion date: August 15, 2020

Study information

• Verified date: January 2020
• Source: Ambry Genetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 15, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Ductal Adenocarcinoma

Intervention

Genetic:
• Multi-gene Next Generation Sequencing Panel
Participants will have genetic testing

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	HonorHealth Research Institute	Scottsdale	Arizona

Sponsors (4)

Lead Sponsor	Collaborator
Ambry Genetics	Beth Israel Deaconess Medical Center, HonorHealth Research Institute, University of Pittsburgh Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Associate age at diagnosis with germline mutation status and family history		18 months
Secondary	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