Clinical trial · Interventional
ACT-GEN (Adherence And Care Tracking In GENetic Cancer Syndromes)
NCT07565467CI-TRIAL-00123556not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To help people with high-risk cancer variants to follow cancer surveillance guidelines and lower their risk of developing the disease.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ACT-GEN | — | UNRESOLVED | — |
| Genetic Cancer Syndromes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interviews | Other | — | UNRESOLVED |
| Standard of care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1: Design and development
- description
- This part of the study is a qualitative study that will include Qualitative Interviews with participants to help design a patient-centered digital application.
- interventionNames
- Other: Interviews
- type
- EXPERIMENTAL
- label
- Part 2: Feasibility study with two-arm randomization
- description
- Patients will be randomized in a 1:1 ratio through REDCap to one of the two study arms described below.
- interventionNames
- Other: Standard of care
Primary outcomes (1)
- measure
- Safety and adverse events (AEs).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.