IGNITE-TX Phase III: (Identifying Individuals for Genetic Testing & Treatment) Intervention

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07318363
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Communication
  • Informed Decision-making

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • IGNITE-TX program — OTHER
    Participants will complete a questionnaire
  • Genetic Counseling and Testing — OTHER
    Participants will complete a questionnaire

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Dec 2025
Primary completion
Apr 1, 2030
Completion
Apr 1, 2032

Study Design

Enrollment
2,100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Standard of Care
    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.
  • Experimental: Free Genetic Counseling and Testing
    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).
  • Experimental: IGNITE-TX Intervention
    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.
  • Experimental: IGNITE-TX Intervention + Free Genetic Counseling and Testing
    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.

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030-

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The University of Texas M. D. Anderson Cancer Center· Houston, TX

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