Recruiting

Genetic Testing

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT06927947

Conditions

Hereditary Malignant Neoplasm

Hereditary Neoplastic Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Communication Intervention

Health Promotion and Education

Informational Intervention

Survey Administration

Study Details

Brief summary:

This clinical trial tests whether various web-based tools can help improve communication about hereditary cancer risk in families and decrease barriers to genetic testing for relatives of patients with hereditary cancer syndromes. Between 5% and 10% of all cancers are caused by genetic changes that are hereditary, which means that they run in families. Some kinds of cancer or certain cancers diagnosed in biological relatives may mean patients are more likely to have a genetic change. Once a genetic change is identified in a family, other biological relatives can choose to undergo testing themselves to better understand their cancer risk. The uptake of genetic testing in other biological relatives once a genetic condition is identified is about 20% to 30%. The Cascade Genetic Testing Platform is a virtual tool that seeks to overcome barriers related to logistics of family communication and improve dissemination of genetic testing information which is clinically actionable for individuals at highest risk for cancer. Using the Cascade Genetic Testing Platform may improve ways to share information about hereditary risk with biological relatives.

Conditions

Hereditary Malignant Neoplasm

Hereditary Neoplastic Syndrome

Study ID

NCT06927947

Start date

Sep 23, 2025

Status verified date

Jun, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • PROBANDS: Clinically confirmed autosomal dominant pathogenic germline variant (PGV) associated with a hereditary cancer syndrome
  • PROBANDS: Previous evaluation by the University of Michigan (U-M) Cancer Genetics Clinic
  • PROBANDS: ≥ 18 years old
  • PROBANDS: Able to speak and read English
  • PROBANDS: Access to the internet
  • RELATIVES: Biological relative of proband
  • RELATIVES: ≥ 18 years old
  • RELATIVES: Able to speak and read English
  • RELATIVES: Access to the internet
  • RELATIVES: Have not completed germline genetic testing, per self-report at baseline

Exclusion Criteria:

  • RELATIVES: Prior clinical germline genetic testing for cancer or already have an upcoming appointment scheduled with a genetics provider, per self-report at baseline

Study Design

Enrollment

625 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Prevention (Cascade Genetic Testing Platform)

PROBANDS: Probands use the relative invitation tool to invite at-risk relatives to participate.

RELATIVES: Participants receive access to the virtual Cascade Genetic Testing Platform, which includes a Genetic Testing Family Letter and access to the VGN. The Genetic Testing Family Letter provides information about the genetic diagnosis in the family, instructions for the relatives on how to schedule a genetic evaluation, and contact information for the U-M Cancer Genetics Clinic. The VGN is an interactive web-based tool that provides personalized information addressing readiness, barriers and motivators to testing, and knowledge, and presents educational content about genetic testing and information about testing options, including how to access them on study.

Interventions

Communication Intervention

Use relative invitation tool

Health Promotion and Education

Receive access to the VGN

Informational Intervention

Receive access to a Genetic Testing Family Letter

Survey Administration

Ancillary studies

Primary outcome measure

  • Percentage of probands that utilize the invitation tool [ Time Frame: Up to 6 Months ]
  • Percentage of invited relatives that engage [ Time Frame: Up to 6 Months ]

Central Contacts and Locations

Central contacts

MiGHT HelpLine

(734) 764-4044MiGHT-Cascade@med.umich.edu

Locations

University of Michigan Comprehensive Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

MiGHT HelpLine

734-764-4044MiGHT-Cascade@med.umich.edu

Principal Investigator:

Elena M. Stoffel

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

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 Michigan Rogel Cancer Center on 2026-06-15.