IGNITE-TX Phase III: (Identifying Individuals for Genetic Testing & Treatment) Intervention
Starting soon · Phase 3
Conditions studied: Communication, Informed Decision-making
In brief
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 facts
- Study ID
- NCT07318363
- Run by
- M.D. Anderson Cancer Center
- People needed
- 2100
- Starts
- 2026-12-01
- Expected to finish
- 2032-04-01
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Probands:
- 18 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.
- Attests to have at least one at-risk relative who meets inclusion criteria for first-degree relative
- For cancer patients who are unaware of their mutation status, we will share existing local and national genetics resources, like those provided in the usual care family letter.
- At-Risk Relatives (ARR):
- 18 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
- SAB:
- Eligible SAB will include any groups connected to HBOC or Lynch syndrome, including those that focus on underserved populations or specific ethnic communities.
- Clinicians:
- Eligible clinicians will include gynecologic oncologists, general gynecologists, medical oncologists, and advanced practice providers who interact with individuals diagnosed with HBOC or Lynch syndrome and/or their at-risk relatives.
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
- SAB:
- SAB members will be excluded if they are not connected to HBOC or Lynch syndrome-related groups or if their organizations do not focus on these conditions or the communities impacted by them.
- Clinicians:
- Clinicians will be excluded if they do not provide direct care to individuals diagnosed with HBOC or Lynch syndrome or their at-risk relatives, or if they do not practice within the specified eligible clinician roles.
Where it is running
- The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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