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

NCT ID: NCT06744595

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-12

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Pancreatic Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Health services research (EPIC message, genetic counseling)

Patients receive a personalized message through EPIC with education on the NCCN guidelines for genetic counseling and an offer for 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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood or salvia samples

Educational Intervention

Intervention Type OTHER

Receive personalized EPIC message

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Genetic Counseling

Intervention Type OTHER

Receive pre-genetic test counseling

Genetic Counseling

Intervention Type OTHER

Receive post-genetic test counseling

Genetic Testing for Cancer Risk

Intervention Type GENETIC

Undergo SOC genetic testing

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Biospecimen Collection

Undergo collection of blood or salvia samples

Intervention Type PROCEDURE

Educational Intervention

Receive personalized EPIC message

Intervention Type OTHER

Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Genetic Counseling

Receive pre-genetic test counseling

Intervention Type OTHER

Genetic Counseling

Receive post-genetic test counseling

Intervention Type OTHER

Genetic Testing for Cancer Risk

Undergo SOC genetic testing

Intervention Type GENETIC

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Cancer Risk Assessment with Genetic Testing and Counseling

Eligibility Criteria

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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)

* Patients with an active or past history of pancreatic cancer
* Patients who are pregnant or breastfeeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrianna D. Clapp, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2024-10177

Identifier Type: REGISTRY

Identifier Source: secondary_id

24-006906

Identifier Type: OTHER

Identifier Source: secondary_id

24-006906

Identifier Type: -

Identifier Source: org_study_id

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