IGNITE-TX Phase III: (Identifying Individuals for Genetic Testing & Treatment) Intervention
2 other identifiers
interventional
2,100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2026
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2025
CompletedFirst Posted
Study publicly available on registry
January 6, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2030
Study Completion
Last participant's last visit for all outcomes
April 1, 2032
January 6, 2026
December 1, 2025
3.8 years
December 29, 2025
December 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Through study completion; an average of 1 year
Study Arms (4)
Standard of Care
EXPERIMENTALARRs: 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.
Free Genetic Counseling and Testing
EXPERIMENTALARRs: 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).
IGNITE-TX Intervention
EXPERIMENTALARRs: 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.
IGNITE-TX Intervention + Free Genetic Counseling and Testing
EXPERIMENTALARRs: 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.
Interventions
Participants will complete a questionnaire
Participants will complete a questionnaire
Eligibility Criteria
You may qualify if:
- Probands:
- years of age or older
- Speaks and reads English or Spanish
- Resides in the United States
- Has a pathogenic or suspected pathogenic variant in BRCA1, BRCA2, MLH1, MSH2/EPCAM, MSH6, or PMS2\*
- Has access to the internet or phone and can send and receive email and/or text messages at a US telephone number.
- At-Risk Relatives (ARR):
- years of age or older
- Speaks and reads English or Spanish
- Resides in the United States
- Has a first or second degree relative who has a deleterious/suspected deleterious HBOC or LS variant present
- Has access to internet or phone and can send and receive email and/or text messages at a US telephone number
You may not qualify if:
- Probands:
- Has no eligible at-risk relatives (ARRs) or is unable/unwilling to provide their contact information
- Has negative germline genetic testing or only variant of uncertain significance
- Unwilling or unable to provide consent
- At-Risk Relatives (ARR):
- Unwilling or unable to provide consent
- Reports no known HBOC or LS variant within the family
- Has already been tested for the variant identified in the proband
- Already listed as an ARR for another proband
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Alejandro Rauh-Hain, MD, MPH
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2025
First Posted
January 6, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
April 1, 2030
Study Completion (Estimated)
April 1, 2032
Last Updated
January 6, 2026
Record last verified: 2025-12