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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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07565467). StuddyBuddy aggregates publicly available trial information.