Genetic Counseling for Family History of Pancreatic Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pancreatic cancer, Pregnant, Breastfeeding

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if personalized education and genetic counseling can encourage more individuals with a family history of pancreatic cancer to undergo genetic testing. Approximately 10% of pancreatic cancer cases have a genetic link, so identifying a risky gene early may lead to more frequent screenings and early detection when the cancer is more treatable. Participants will receive information about current guidelines and expert counseling, and they may opt for genetic testing. This trial suits patients at Mayo Clinic Florida who have a parent, sibling, or child with pancreatic cancer. As an unphased trial, it offers participants a unique opportunity to contribute to important research that could enhance early detection strategies for pancreatic cancer.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this genetic counseling and personalized education is safe?

Research has shown that personalized education and genetic counseling are generally safe and manageable. These methods do not involve medication or medical procedures, so they have no known physical side effects. Instead, they offer information and support to help individuals understand their genetic risk for pancreatic cancer.

Studies have found that genetic counseling often leaves people feeling more informed and less anxious about their health risks. This support can assist them in deciding whether to undergo genetic testing. No reports of harmful effects from this approach suggest it is a safe option for those with a family history of pancreatic cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on a personalized approach to genetic counseling for individuals with a family history of pancreatic cancer. Unlike typical genetic counseling that might follow a more standardized format, this trial uses a personalized message through EPIC, which educates patients based on the NCCN guidelines and offers tailored counseling sessions. This personalized education aims to empower patients with specific information about their risks and options, potentially leading to more informed decision-making. Additionally, the trial includes optional genetic testing and collection of blood or saliva samples, which provides a comprehensive approach to understanding and managing hereditary cancer risks.

What evidence suggests that personalized education and genetic counseling might be effective for increasing genetic testing in patients with a family history of pancreatic cancer?

Research has shown that personalized education and genetic counseling, which participants in this trial will receive, can increase the number of people undergoing genetic testing for cancer risks, particularly in families with a history of pancreatic cancer. In one study with 601 participants, 90% chose to have multi-gene panel testing (MGPT), a type of genetic test, after receiving counseling. This finding indicates that understanding family history and guidelines makes individuals more likely to get tested. The National Comprehensive Cancer Network (NCCN) recommends genetic counseling for those with a close family member who has pancreatic cancer. This approach may help detect cancer early when it is easier to treat. ^{1 4 6 7 8}

Who Is on the Research Team?

Adrianna D. Clapp, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with a family history of pancreatic cancer, specifically those who have a first-degree relative (parent, sibling, child) affected by the disease. It aims to see if personalized education and genetic counseling can increase their participation in genetic testing.

Inclusion Criteria

Active patient at Mayo Clinic Florida (MCF) with visits within 1/1/2023-12/31/2023 to Family Medicine and/or Gastroenterology and Hepatology

A close family member has had pancreatic cancer.

Exclusion Criteria

Patients not meeting the inclusion criteria as defined above

Patients who are pregnant or breastfeeding

I have or had pancreatic cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education and Counseling

Participants receive personalized education on NCCN guidelines and pre-genetic test counseling

Up to 75 days

1 visit (virtual)

Genetic Testing

Participants may optionally undergo SOC genetic testing and provide blood or saliva samples

1-2 weeks

Follow-up

Participants receive post-genetic test counseling and are monitored for understanding and adherence to NCCN guidelines

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Education and Genetic Counseling

Trial Overview The study tests whether providing tailored educational materials about pancreatic cancer risks and guidelines, along with professional genetic counseling, encourages patients to undergo genetic testing that could help in early detection.

How Is the Trial Designed?

Group I: Health services research (EPIC message, genetic counseling) Experimental Treatment 6 Interventions

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06744595

Personalized Education and Genetic Counseling to ... This clinical trial studies whether personalized education and genetic counseling increases genetic testing in patients with a known family history of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11034726/

The Genetic Education, Risk Assessment, and Testing ... Genetic testing uptake for cancer susceptibility in family members of cancer patients is suboptimal. Among relatives of pancreatic ductal adenocarcinoma ...

3. gastrojournal.org gastrojournal.org/article/S0016-5085(24)00129-X/fulltext

The Genetic Education, Risk Assessment, and Testing ... In this randomized study of 601 participants with familial/genetic risk of PDAC, 90% of study participants pursued MGPT through 1 of 2 remotely ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-10177

Personalized Education and Genetic Counseling to ... Personalized education is based on the patient's family history of pancreatic cancer and offers information regarding the current NCCN guidelines. This may be ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.4_suppl.688

Guideline compliance and outcomes of genetic testing in ... The aim of this study was to evaluate compliance with recently updated guidelines (May 2019) and assess subsequent uptake and outcomes of genetic testing in ...

6. withpower.com withpower.com/trial/phase-pancreatic-neoplasms-2025-9f5b8

Genetic Counseling for 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9938327/

Identification of individuals at high-risk for pancreatic ... Individuals who met the criteria for a significant family history of cancer were offered referral to a genetic counselor. The questionnaire was completed by 453 ...

8. mayo.edu mayo.edu/research/clinical-trials/cls-20577123

Genetic Testing with Family History of Pancreatic Cancer The purpose of this study is perform HOUSES index analysis on 500 patients with a first-degree relative diagnosed with pancreatic cancer to see if there is a ...