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Not Yet Recruiting
NCT07565467
ACT-GEN (Adherence And Care Tracking In GENetic Cancer Syndromes)
Conditions: ACT-GEN, Genetic Cancer Syndromes
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: M.D. Anderson Cancer Center
Location: MD Anderson Cancer Center Houston Texas
Summary
To help people with high-risk cancer variants to follow cancer surveillance guidelines and lower their risk of developing the disease.
Eligibility Criteria
Eligibility Criteria
Part 1 inclusion criteria:
1. Female participants.
2. 18 years of age or older;
3. With known deleterious/pathogenic mutation or likely pathogenic/deleterious variant in HBOC genes (BRCA1/2) or Lynch associated genes (MLH1, MSH2, MSH6, PMS2, EPCAM);
4. Speaks and reads English or Spanish; and
5. Has access to a smartphone with operating system compatible with iOS/Android applications.
Part 2 inclusion criteria:
1. Female participants.
2. With known deleterious/pathogenic mutation or likely pathogenic/deleterious variant in HBOC genes (BRCA1/2) or Lynch associated genes (MLH1, MSH2, MSH6, PMS2, EPCAM);
3. Age criteria met by pathogenic variants as listed below:
1. BRCA1 pathogenic variant or deleterious mutation: ≥ 35 years old
2. BRCA2 pathogenic variant or deleterious mutation: ≥ 40 years old
3. MLH1 pathogenic variant or deleterious mutation: ≥ 20 years old
4. MSH2 pathogenic variant or deleterious mutation: ≥ 20 years old
5. MSH6 pathogenic variant or deleterious mutation: ≥ 30 years old
6. PMS2 pathogenic variant or deleterious mutation: ≥ 30 years old
7. EPCAM pathogenic variant or deleterious mutation: ≥ 20 years old
4. Speaks and reads English or Spanish.
5. Has access to a smartphone with operating system compatible with iOS/Android applications; and
6. Has not previously undergone bilateral salpingo-oophorectomy.
Exclusion Criteria
Part 1 exclusion criteria:
1. Unwilling or unable to provide consent; or
2. Does not have access to a smartphone or is unable to access the application on their phone;
Part 2 exclusion criteria:
1. Unwilling or unable to provide consent;
2. No deleterious or pathogenic variant in HBOC genes (BRCA1/2), or Lynch associated genes (MLH1, MSH2, MSH6, PMS2, or EPCAM);
3. Does not have access to a smartphone or is unable to access the application on their phone.
4. Actively being treated for malignancy with cytotoxic therapy.
5. History of gynecologic or breast malignancy; or
6. Has previously undergone bilateral salpingo-oophorectomy (for BRCA1/2).
7. Participated in Part 1.
Source: ClinicalTrials.gov (NCT07565467). StuddyBuddy aggregates publicly available trial information.