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OpenTrials
Enrolling by Invitation

NCT Number: NCT06744595

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

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.

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Key information

Conditions

Pancreatic Carcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of blood or salvia samples

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Educational Intervention

Other

Receive personalized EPIC message

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Electronic Health Record Review

Other

Ancillary studies

Genetic Counseling

Other

Receive pre- and post-genetic test counseling

Genetic Testing for Cancer Risk

Genetic

Undergo standard of care (SOC) genetic testing

Other names: Cancer Risk Assessment with Genetic Testing and Counseling

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. 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

  1. Number of patients meeting NCCN guidelines

    Time frame: Up to 75 days

    Will determine if portal message communication can improve the number of patients who meet NCCN guidelines at Mayo Clinic in Florida and understand their experiences.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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