[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617418":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":36,"centralContacts":40,"locations":45,"responsibleParty":59,"collaborators":32,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":32,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":32,"enrollmentInfo":70,"targetDuration":32,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":32,"overallStatus":80,"whyStopped":32,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care","EXPERIMENTAL","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.",[13,14],"Other: IGNITE-TX program","Other: Genetic Counseling and Testing",{"label":16,"type":10,"description":17,"interventionNames":18},"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).",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"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.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"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.",[13,14],[28,33],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"IGNITE-TX program","Participants will complete a questionnaire",[16,20,24,9],null,{"type":6,"name":34,"description":30,"armGroupLabels":35,"otherNames":32},"Genetic Counseling and Testing",[16,20,24,9],[37],{"name":38,"affiliation":5,"role":39},"Jose Alejandro Rauh-Hain, MD, MPH","PRINCIPAL_INVESTIGATOR",[41],{"name":38,"role":42,"phone":43,"phoneExt":32,"email":44},"CONTACT","(713) 794-1759","jarauh@mdanderson.org",[46],{"facility":47,"status":32,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":32},"The University of Texas M. D. Anderson Cancer Center","Houston","Texas","77030","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-95.36327,29.76328,{"lat":57,"lon":56},{"type":60,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100617418","phase-3-ignite-tx-phase-iii-identifying-individuals-for-genetic-testing--treatment-intervention-100617418",false,"NCT07318363","IGNITE-TX Phase III: (Identifying Individuals for Genetic Testing & Treatment) Intervention","Inclusion Criteria:\n\nProbands:\n\n1. 18 years of age or older\n2. Speaks and reads English or Spanish\n3. Resides in the United States\n4. Has a pathogenic or suspected pathogenic variant in BRCA1, BRCA2, MLH1, MSH2\u002FEPCAM, MSH6, or PMS2\\*\n5. Has access to the internet or phone and can send and receive email and\u002For text messages at a US telephone number.\n6. 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.\n\nAt-Risk Relatives (ARR):\n\n1. 18 years of age or older\n2. Speaks and reads English or Spanish\n3. Resides in the United States\n4. Has a first or second degree relative who has a deleterious\u002Fsuspected deleterious HBOC or LS variant present\n5. Has access to internet or phone and can send and receive email and\u002For text messages at a US telephone number\n\nExclusion Criteria:\n\nProbands:\n\n1. Has no eligible at-risk relatives (ARRs) or is unable\u002Funwilling to provide their contact information\n2. Has negative germline genetic testing or only variant of uncertain significance\n3. Unwilling or unable to provide consent\n\nAt-Risk Relatives (ARR):\n\n1. Unwilling or unable to provide consent\n2. Reports no known HBOC or LS variant within the family\n3. Has already been tested for the variant identified in the proband\n4. Already listed as an ARR for another proband",true,"ALL","18 Years",{"count":71,"type":72},2100,"ESTIMATED","INTERVENTIONAL",[75],"PHASE3","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\u002Fcounseling, and intervention with free genetic testing\u002Fcounseling.",[78,79],"Communication","Informed Decision-making","NOT_YET_RECRUITING","2025-12-29",{"date":83,"type":84},"2026-01-06","ACTUAL",{"date":86,"type":72},"2026-06-01",{"date":88,"type":72},"2032-04-01",{"name":5,"class":6},1]