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

NCT02790944 | Completed

• 1 other identifier: NEX_14_028
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

Germline; Pancreatic; Genetic Testing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Associate age at diagnosis with germline mutation status and family history

  18 months

• Access the psychological impact of testing for hereditary pancreatic cancer

  18 months

Interventions

Multi-gene Next Generation Sequencing Panel GENETIC

Participants will have genetic testing

Also known as: CancerNext

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ambry Genetics: lead
• Beth Israel Deaconess Medical Center: collaborator
• University of Pittsburgh Medical Center: collaborator
• HonorHealth Research Institute: collaborator

Study Sites (3)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215-5400, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Related 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.

  PMID: 12433008 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood, saliva or DNA

Study Officials

• Randall Brand, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Nadine Tung, MD

  Beth Israel Deaconess

  PRINCIPAL INVESTIGATOR

• Erkut Borazanci, MD

  HonorHealth Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 6, 2016
• Study Start: May 4, 2016
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2020
• Last Updated: August 25, 2020

Record last verified: 2020-01

Locations

US (3)