Recruiting

Genetic Information

Sponsor:

University of Virginia

Code:

NCT06089421

Conditions

Gene Mutation-Related Cancer

Genetic Predisposition

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Genetic Information Assistant

Telegenetics with UVA genetic counselor

Study Details

Brief summary:

The goal of this clinical trial is to learn about different ways cancer genetic screening can be provided to rural communities in participants at high risk for certain cancers. The main question it aims to answer is:

• Does receiving pre-genetic test education with a chat bot or genetic counselor affect if the participant decides to get genetic testing?

Participants will:

  • have a pre-test genetic counselling session with a genetic counselor or the GIA chatbot
  • answer questions about their cancer genetic knowledge and how they are doing
  • provide a saliva sample for genetic testing to test for cancer gene mutations
  • have their genetic testing results provided to them.
  • have the option to share their genetic testing results with family members

Researchers will compare how many participants who had pre-genetic counseling with the chatbot received genetic testing to how many participants who had pre-genetic counseling with a genetic counselor received genetic testing.

Conditions

Gene Mutation-Related Cancer

Genetic Predisposition

Study ID

NCT06089421

Start date

Apr 1, 2025

Status verified date

Sep, 2025

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • At high risk for having a genetic pathogenic variant as assessed by a GC or physician according to the NCCN guidelines
  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Male or female, aged 18 and over.
  • Subjects must have a smartphone with access to cellular and/or internet service or a computer with internet service.
  • Subjects must have technological competency/proficiency to use their Smartphone and/or computer in conjunction with the communication aid GIA.

Exclusion Criteria:

  • Cannot communicate in English or Spanish.
  • Subjects must not have completed panel-based cancer genetic testing in the past.

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

active comparator: Standard of care telegenetics with a UVA genetic counselor (GC) for pre-test counseling

Pre-genetic test counselling with a genetic counselor from the University of Virginia

experimental: Novel interventional arm of pre-test counseling via GIA

Pre-genetic test counselling through novel chat bot Genetic Information Assistant (GIA)

Interventions

Genetic Information Assistant

Participants assigned will receive a link to Genetic Information Assistant for pre-test counseling.

Telegenetics with UVA genetic counselor

Participants assigned will have a pre-test counseling session via a telegentics visit with a genetic counselor.

Primary outcome measure

  • To assess feasibility of using a chatbot (GIA) for pre-test genetic counseling compared to standard of care GC [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Evelyn Villalobos

(434) 297-4579EV4PD@uvahealth.org

Joseph Petruzziello

(434) 323-1749BNW4RM@uvahealth.org

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22930

More Information

Sponsor

University of Virginia

Last update posted

Sep 23, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2025-09-23.