IGNITE-TX Phase III: (Identifying Individuals for Genetic Testing & Treatment) Intervention
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About 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.
Eligibility criteria
Qualifiers
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*
Disqualifiers
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
Unwilling or unable to provide consent
Trial design
Treatments tested in this trial
- IGNITE-TX program
- Genetic Counseling and Testing
Treatment groups
2,100 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov