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Personalized Education and Genetic Counseling to Increase Genetic Testing in Patients With a Known Family History of Pancreatic Cancer

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06744595
Enrollment
50
Registered
2024-12-20
Start date
2025-02-12
Completion date
2026-06-30
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Carcinoma

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.

Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood or salvia samples

OTHEREducational Intervention

Receive personalized EPIC message

OTHERElectronic Health Record Review

Ancillary studies

OTHERGenetic Counseling

Receive pre- and post-genetic test counseling

Undergo standard of care (SOC) genetic testing

OTHERSurvey Administration

Ancillary studies

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Demographic factors affecting likelihood of patients meeting National Comprehensive Cancer Network (NCCN) guidelinesUp to 75 daysWill 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

MeasureTime frameDescription
Number of patients meeting NCCN guidelinesUp to 75 daysWill determine if portal message communication can improve the number of patients who meet NCCN guidelines at Mayo Clinic in Florida and understand their experiences.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAdrianna D. Clapp, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026