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Clinical Trials/NCT06744595
NCT06744595
Enrolling By Invitation
Not Applicable

Evaluation of Genetic Testing for Patients With Known Family History of Pancreatic Cancer: A Pilot Study

Mayo Clinic1 site in 1 country40 target enrollmentFebruary 12, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pancreatic Carcinoma
Sponsor
Mayo Clinic
Enrollment
40
Locations
1
Primary Endpoint
Demographic factors affecting likelihood of patients meeting National Comprehensive Cancer Network (NCCN) guidelines
Status
Enrolling By Invitation
Last Updated
4 months ago

Overview

Brief Summary

This clinical trial studies whether personalized education and genetic counseling increases genetic testing in patients with a known family history of pancreatic cancer. Approximately 10% of pancreatic cancer cases are genetically linked and therefore, if a gene is found that could put a patient at risk, it could guide the patient to obtain more frequent screening for pancreatic cancer and possibly detect it earlier when it is more treatable. The current National Comprehensive Cancer Network (NCCN) guidelines suggest patients with a first-degree relative (parent, sibling, child) with pancreatic cancer be referred for a genetics consultation to discuss genetic testing if the affected family member cannot be tested. Personalized education is based on the patient's family history of pancreatic cancer and offers information regarding the current NCCN guidelines. This may be an effective method to increase patients' understanding of their pancreatic cancer risk and the NCCN guidelines. Genetic counseling is provided by an expert in hereditary disorders. The patient's family and personal medical history may be discussed, and counseling may lead to genetic testing. Personalized education and genetic counseling may increase genetic testing in patients with a known family history of pancreatic cancer.

Detailed Description

PRIMARY OBJECTIVES: I. Perform Housing-Based Socioeconomic Status (HOUSES) index analysis on 500 patients with a first-degree relative diagnosed with pancreatic cancer to see if there is a correlation with the National Comprehensive Cancer Network (NCCN) criteria. II. Offer 40 patients who did not have appropriate NCCN intervention the opportunity to have a genetic consultation (to consider genetic testing). III. Survey patients on their knowledge and experiences of genetic testing based on family history and their decision-making when offered genetic counseling and testing. OUTLINE: Patients receive a personalized message through the Mayo portal (EPIC) with education on the NCCN guidelines for genetic counseling and an offer for standard of care (SOC) genetic counseling. Patients then receive pre-genetic test counseling on study. Patients may then optionally undergo SOC genetic testing and collection of blood or saliva samples as well as receive post-genetic test counseling on study.

Registry
clinicaltrials.gov
Start Date
February 12, 2025
End Date
June 30, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age: 18-75 years of age
  • First-degree relative with pancreatic cancer listed in the EPIC family history tool
  • Active patient at Mayo Clinic Florida (MCF) (visits within 1/1/2023-12/31/2023 to Family Medicine and/or Gastroenterology and Hepatology)

Exclusion Criteria

  • Patients not meeting the inclusion criteria as defined above
  • Patients with an active or past history of pancreatic cancer
  • Patients who are pregnant or breastfeeding

Outcomes

Primary Outcomes

Demographic factors affecting likelihood of patients meeting National Comprehensive Cancer Network (NCCN) guidelines

Time Frame: Up to 75 days

Will determine whether demographic factors, including socioeconomic status, affect the likelihood of a patient meeting NCCN guidelines regarding genetic counseling for those with a family history of pancreatic cancer.

Secondary Outcomes

  • Number of patients meeting NCCN guidelines(Up to 75 days)

Study Sites (1)

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