Systematic Hereditary Pancreatic Cancer Risk Assessment And Implications For Personalized Therapy

Study Overview

Systematic Hereditary Pancreatic Cancer Risk Assessment and Implications for Personalized Therapy

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

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.

Pancreatic Cancer

16-448
P50CA127003 (U.S. NIH Grant/Contract)

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 2017-02-15	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-03-12
First Submitted that Met QC Criteria 2017-02-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-03-14
First Posted (ACTUAL) 2017-02-23	Results First Posted N/A	Last Verified 2025-03

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
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	Measure Description	Time Frame
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

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:

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

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

Collaborators and Investigators

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

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Matthew B Yurgelun, MD, Dana-Farber Cancer Institute

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

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record