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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
IGNITE-TX program
Other interventionParticipants will complete a questionnaire
Genetic Counseling and Testing
Other interventionParticipants will complete a questionnaire
Treatment groups
2,100 Participants
are divided into 4 treatment groupsGroup A: Standard of CareExperimental treatment 2 interventions
Group B: Free Genetic Counseling and TestingExperimental treatment 2 interventions
Group C: IGNITE-TX InterventionExperimental treatment 2 interventions
Group D: IGNITE-TX Intervention + Free Genetic Counseling and TestingExperimental treatment 2 interventions
Trial outcomes
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
Time frame
Through study completion; an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: