Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy

Active, not recruiting

• Conditions: Pancreatic Cancer

• Registration Number: NCT03060720
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

This research study is looking at people with cancer of the pancreas to find clinical factors that can explain the presence of genetic mutations

Detailed Description

This research is being done to identify which pancreatic cancer patients should undergo genetic evaluation. A patient's personal and family history of cancer is the information typically used to make this decision, but there are currently no accurate, evidence-based guidelines that exist to help doctors use this information to make a decision.

The investigators hope that by testing all new pancreatic cancer patients, they can determine which clinical factors predict for genetic mutations in order to create a risk assessment tool.

The investigators want to determine which patients with pancreatic cancer will benefit from genetic testing. To do so, the investigators will offer all patients with pancreatic cancer in the Dana-Farber Gastrointestinal Oncology clinic referral for genetic evaluation. At the Cancer Genetics and Prevention clinic appointment, the provider will review the patient's personal and familial history of cancer and offer genetic testing.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-17
• Study First Posted: 2017-02-23
• Study Start: 2017-02-24
• Primary Completion: 2019-04-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 271

Inclusion Criteria

• Diagnosis of pancreatic ductal adenocarcinoma
• Signed initial informed consent
• Participant agrees to genetic counseling

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Exclusion Criteria

• Prospective participant unable to sign informed consent based on referring physician recommendation.
• Patient has neuroendocrine pancreatic tumor

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
We will measure clinical factors (e.g. # of PDAC patients with a personal history of x,y,z; # of PDAC patients with a family history of x,y,z; # PDAC patients with a germline mutation in x,y,z) so as to develop a risk assessment tool	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Evaluate Patient Experience With Genetic Testing	up to 5 years
Summarize patient satisfaction with Genetic counseling	up to 5 years
Number of patients who disclose genetic testing results to relatives	up to 5 years

Trial Locations

Locations (1)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States