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Not yet recruiting NCT07565467

ACT-GEN (Adherence And Care Tracking In GENetic Cancer Syndromes)

No phase Interventional ACT-GEN Genetic Cancer Syndromes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard of care, Interviews.
Who it may be relevant to
Registry conditions: ACT-GEN, Genetic Cancer Syndromes. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

To help people with high-risk cancer variants to follow cancer surveillance guidelines and lower their risk of developing the disease.

Detailed description

Primary Objective

1\. The primary objective of this study is to assess feasibility of the intervention by achieving benchmarks, including:

1. Design and development of the iPhone/Android application; 2. Collation of a network of providers with expertise in BRCA1/2 and Lynch Syndrome by state/region for enrolled participants; 3. Enrollment of participants within a 6-month period; 4. Engagement of participants via standardized digital user analytics (number of downloads, active users, monthly active users, conversion rate); and 5. Completion of baseline and interval surveys

Interventions

  • Other Standard of care
    Standard of Care, no efforts will be made toward any of the study objectives
  • Other Interviews
    Up to three interviews may be conducted per participant, and they may take place remotely via a secure videoconferencing service to limit disruptions to the participants schedule as well as any financial burden associated with travel.

Primary outcome measures

  • Safety and adverse events (AEs). [Time frame: Through study completion; an average of 1 year]

Eligibility criteria

Eligibility Criteria

Part 1 inclusion criteria:

  • Female participants.
  • 18 years of age or older;
  • With known deleterious/pathogenic mutation or likely pathogenic/deleterious variant in HBOC genes (BRCA1/2) or Lynch associated genes (MLH1, MSH2, MSH6, PMS2, EPCAM);
  • Speaks and reads English or Spanish; and
  • Has access to a smartphone with operating system compatible with iOS/Android applications.

Part 2 inclusion criteria:

  • Female participants.
  • With known deleterious/pathogenic mutation or likely pathogenic/deleterious variant in HBOC genes (BRCA1/2) or Lynch associated genes (MLH1, MSH2, MSH6, PMS2, EPCAM);
  • Age criteria met by pathogenic variants as listed below:
  • BRCA1 pathogenic variant or deleterious mutation: ≥ 35 years old
  • BRCA2 pathogenic variant or deleterious mutation: ≥ 40 years old
  • MLH1 pathogenic variant or deleterious mutation: ≥ 20 years old
  • MSH2 pathogenic variant or deleterious mutation: ≥ 20 years old
  • MSH6 pathogenic variant or deleterious mutation: ≥ 30 years old
  • PMS2 pathogenic variant or deleterious mutation: ≥ 30 years old
  • EPCAM pathogenic variant or deleterious mutation: ≥ 20 years old
  • Speaks and reads English or Spanish.
  • Has access to a smartphone with operating system compatible with iOS/Android applications; and
  • Has not previously undergone bilateral salpingo-oophorectomy.

Exclusion criteria

Part 1 exclusion criteria:

  • Unwilling or unable to provide consent; or
  • Does not have access to a smartphone or is unable to access the application on their phone;

Part 2 exclusion criteria:

  • Unwilling or unable to provide consent;
  • No deleterious or pathogenic variant in HBOC genes (BRCA1/2), or Lynch associated genes (MLH1, MSH2, MSH6, PMS2, or EPCAM);
  • Does not have access to a smartphone or is unable to access the application on their phone.
  • Actively being treated for malignancy with cytotoxic therapy.
  • History of gynecologic or breast malignancy; or
  • Has previously undergone bilateral salpingo-oophorectomy (for BRCA1/2).
  • Participated in Part 1.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • MD Anderson Cancer Center — Houston

Identifiers

NCT: NCT07565467 · 2026-0038 · NCI-2026-03287

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗