Breast Cancer Clinical Trial
Official title:
Feasibility Study: IGNITE-TX (Identifying Individuals for Genetic Testing & Treatment) Intervention
This is a community-based study requiring participant-self-enrollment, that can help to increase the rates of genetic testing among the family members of people who have been diagnosed with a hereditary cancer syndrome. The two main factors in this study are the IGNITE-TX intervention (website and navigator) and the free genetic counseling and testing. The IGNITE-TX Intervention is an innovative multi-modal intervention, with two components: a) interactive web "IGNITE-TX Hub" and b) genetic family navigators.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | October 31, 2027 |
Est. primary completion date | October 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Probands Inclusion Criteria: 1. 18 years of age or older 2. Speaks and/or reads English or Spanish 3. Has known deleterious/pathogenic mutation or suspected deleterious/pathogenic variant in BRCA1 or BRCA2 (HBOC) or MLH1, MSH2, MSH6, PMS2, or EPCAM (LS) 4. Has access to the internet or phone and can send and receive email and/or text messages at a US telephone number 5. Has at least one at-risk relative who meets inclusion criteria for first-degree relative Exclusion Criteria: 1. Has no at-risk relatives meeting inclusion criteria 2. Has negative germline genetic testing or only variant of uncertain significance 3. Unwilling or unable to provide consent 4.2. AT-RISK RELATIVES (ARR) Inclusion Criteria: 1. 18 years of age or older 2. Speaks and reads English or Spanish 3. Resides in the United States 4. Can provide proof of deleterious/suspected deleterious HBOC or LS variant present in a first degree relative (biological mother or father, biological child, or full sibling) 5. Has access to internet or phone and can send and receive email and/or text messages at a US telephone number Exclusion Criteria: 1. Unwilling or unable to provide consent 2. Reports no known HBOC or LS variant within the family 3. Has already been tested for the variant identified in the proband 4. Already listed as an ARR for another proband |
Country | Name | City | State |
---|---|---|---|
United States | MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measure enrollment of probands and at-risk relatives over a 6-month period | Up to 6 months | ||
Primary | Measure response rate to baseline and follow-up surveys by probands and at-risk relatives | Up to 6 months |
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