NCT07565467

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
78mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

October 8, 2026

Expected
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2031

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2033

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

4.4 years

First QC Date

April 27, 2026

Last Update Submit

April 27, 2026

Conditions

ACT-GENGenetic Cancer Syndromes

Outcome Measures

Primary Outcomes (1)

  • Safety and adverse events (AEs).

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Through study completion; an average of 1 year

Study Arms (2)

Part 1: Design and development

EXPERIMENTAL

This part of the study is a qualitative study that will include Qualitative Interviews with participants to help design a patient-centered digital application.

Other: Interviews

Part 2: Feasibility study with two-arm randomization

EXPERIMENTAL

Patients will be randomized in a 1:1 ratio through REDCap to one of the two study arms described below.

Other: Standard of care

Interventions

Standard of careOTHER

Standard of Care, no efforts will be made toward any of the study objectives

Part 2: Feasibility study with two-arm randomization
InterviewsOTHER

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.

Part 1: Design and development

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female participants.
  • 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.
  • 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
  • +3 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

Standard of CareInterviews as Topic

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Officials

  • Jose Rauh-Hain, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Rauh-Hain, MD

CONTACT

713-794-1759jarauh@mdanderson.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 4, 2026

Study Start (Estimated)

October 8, 2026

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2033

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

US(1)