Recruiting

Genetic Services

Sponsor:

University of Alabama at Birmingham

Code:

NCT07106359

Conditions

Cascade Testing

Lynch Syndrome

Decision Making

Colorectal Cancer

Uterine Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Information Letter and Booklet

Information Letter

Study Details

Brief summary:

The purpose of the study is to see if our education materials help people at risk for Lynch syndrome decide about seeking genetic services. Untested relatives of patients with Lynch syndrome will be recruited to complete a baseline survey and will be randomized to receive either the an information letter or an information letter plus a booklet. Two follow-up surveys will be administered over the span of 6 months. Participants will also be invited to join an optional exit interview to provide feedback.

Conditions

Cascade Testing

Lynch Syndrome

Decision Making

Colorectal Cancer

Uterine Cancer

Study ID

NCT07106359

Start date

Sep 15, 2025

Status verified date

Jul, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Probands Inclusion Criteria:

  • English speaking
  • at least 18 years old
  • have had genetic testing for Lynch syndrome (LS)
  • do not have a condition that would interfere with their ability to provide informed consent and complete study activities (e.g., cognitive dysfunction evaluated using clinical judgment during screening)

Clinical Trial Participants Inclusion Criteria:

  • English-speaking
  • at least 18 years old
  • a blood relative of a patient who was diagnosed with LS
  • potentially at risk for LS
  • have not scheduled or had pre-test genetic counseling or genetic testing for LS
  • do not have a personal history of a cancer (excluding non-melanoma skin cancer)
  • do not have a condition that would interfere with their ability to provide informed consent and complete study activities (e.g., cognitive dysfunction evaluated using clinical judgment during screening)

Study Design

Enrollment

185 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Information Letter

This arm provides an information letter about Lynch syndrome and genetic services.

experimental: Information Letter and Booklet

This arm provides an information letter with a booklet about Lynch syndrome and genetic services.

Interventions

Information Letter and Booklet

an information letter with a booklet for at-risk families highlighting implications of family history, testing considerations, steps for genetic testing, and potential costs.

Information Letter

an information letter with basic information about LS and implications of counseling and testing of LS, and a few websites for more information and locating genetic counselors.

Primary outcome measure

  • Feasibility (recruitment and retention rates, completeness of assessment data) [ Time Frame: (recruitment) baseline, 1-month and 6-months post-randomization ]
  • Use and attitudes towards the education materials [ Time Frame: 1-month post-randomization (may also include in 6-month post-randomization ]
  • Scheduling and attendance of pre-test genetic counseling and/or genetic testing [ Time Frame: 6-months post-randomization ]

Central Contacts and Locations

Central contacts

Haoyang Yan, PhD

205-914-2249LSPilotStudy@uabmc.edu

Kaylee Burgan, MS

205-914-2249LSPilotStudy@uabmc.edu

Locations

UAB

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

study team

205-914-2249LSPilotStudy@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-07-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.