IGNITE-TX Program for Genetic Counseling

Overseen By Jose Alejandro Rauh-Hain, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Negative genetic test, No consent, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to implement and compare an evidence- and theory-based intervention strategy (IGNITE-TX Intervention) to support probands and their ARRs in family communication, informed decision-making, and navigation to CGT with standard of care, free genetic testing/counseling, and intervention with free genetic testing/counseling.

Who Is on the Research Team?

Jose Alejandro Rauh-Hain, MD, MPH

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for U.S. residents aged 18 or older who speak English or Spanish, have certain genetic mutations (BRCA1/2, MLH1, MSH2/EPCAM, MSH6, PMS2), and can communicate via internet or phone. They must also have a first or second degree relative with these mutations and at least one at-risk relative.

Inclusion Criteria

I can use the internet or a phone and can email or text to a US number.

I have a genetic mutation linked to cancer in BRCA1, BRCA2, MLH1, MSH2/EPCAM, MSH6, or PMS2.

I can speak and read English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the IGNITE-TX intervention, which includes family communication support and navigation to cascade genetic testing

6 months

Follow-up

Participants are monitored for safety and effectiveness after intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Genetic Counseling and Testing
• IGNITE-TX program

Trial Overview

The IGNITE-TX Phase III trial tests an intervention strategy to help individuals understand their genetic risks and make informed decisions about genetic testing and counseling compared to standard care which includes free testing/counseling.

How Is the Trial Designed?

Group I: Standard of Care Experimental Treatment 2 Interventions

ARRs: No active efforts will be made to ensure that ARRs complete genetic testing or to support family communication and education during the period in which primary study outcomes are being evaluated.

Group II: IGNITE-TX Intervention + Free Genetic Counseling and Testing Experimental Treatment 2 Interventions

ARRs: The relative will be sent instructions to access free counseling and testing, as well as a unique code to log into the IGNITE-TX Hub (Appendix K \& L). Family Genetic Navigators will support this process by reaching out and guiding relatives through both resources.

Group III: IGNITE-TX Intervention Experimental Treatment 2 Interventions

ARRs: The relatives will receive instructions with a code to access the IGNITE-TX Hub (Appendix K \& L). Family Genetic Navigators will support this process by reaching out and guiding relatives through the process.

Group IV: Free Genetic Counseling and Testing Experimental Treatment 2 Interventions

ARRs: A letter will be provided to the ARR with instructions on how to access genetic counseling and free testing through a telegenetics company (Appendix E).

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+