ACT-GENNCT07565467
ACT-GEN (Adherence And Care Tracking In GENetic Cancer Syndromes)
A study testing Interviews in people with ACT-GEN and Genetic Cancer Syndromes, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To help people with high-risk cancer variants to follow cancer surveillance guidelines and lower their risk of developing the disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- ACT-GEN, Genetic Cancer Syndromes
- What is being tested?
- Interviews
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2026to 1 Mar 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
MD Anderson Cancer Center
Houston, Texas, 77030
Jose Rauh-Hain, MD, 713-794-1759, jarauh@mdanderson.org
Jose Rauh-Hain, MD
About this study
To help people with high-risk cancer variants to follow cancer surveillance guidelines and lower their risk of developing the disease.
Read the detailed description
Primary Objective
- The primary objective of this study is to assess feasibility of the intervention by achieving benchmarks, including:
- Design and development of the iPhone/Android application;
- Collation of a network of providers with expertise in BRCA1/2 and Lynch Syndrome by state/region for enrolled participants;
- Enrollment of participants within a 6-month period;
- Engagement of participants via standardized digital user analytics (number of downloads, active users, monthly active users, conversion rate); and
- Completion of baseline and interval surveys
- Conditions
- ACT-GEN, Genetic Cancer Syndromes
- Being tested
- Standard of care, Interviews
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
Standard of Care, no efforts will be made toward any of the study objectives
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start8 Oct 2026 (estimated)
- Primary completion1 Mar 2031 (estimated)
- Study completion1 Mar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACT-GENStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Rauh-Hain, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565467
- Sponsor's protocol ID
- 2026-0038
- Other IDs
- NCI-2026-03287
- Status last verified
- Aug 2026
- First submitted
- 27 Apr 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACT-GEN (Adherence And Care Tracking In GENetic Cancer Syndromes)
- ClinicalTrials.gov ID
- NCT07565467
- Acronym / sponsor ID
- 2026-0038
- Conditions
- ACT-GEN, Genetic Cancer Syndromes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 1 Mar 2031 (estimated)
- Study completion
- 1 Mar 2033 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- The primary objective of this study is to assess feasibility of the intervention by achieving benchmarks, including:
- Design and development of the iPhone/Android application;
- Collation of a network of providers with expertise in BRCA1/2 and Lynch Syndrome by state/region for enrolled participants;
- Enrollment of participants within a 6-month period;
- Engagement of participants via standardized digital user analytics (number of downloads, active users, monthly active users, conversion rate); and
- Completion of baseline and interval surveys
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Design and development | Experimental | Other: InterviewsThis part of the study is a qualitative study that will include Qualitative Interviews with participants to help design a patient-centered digital application. |
| Part 2: Feasibility study with two-arm randomization | Experimental | Other: Standard of carePatients will be randomized in a 1:1 ratio through REDCap to one of the two study arms described below. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of careStandard of Care, no efforts will be made toward any of the study objectives | Other | Part 2: Feasibility study with two-arm randomization |
| InterviewsUp 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. | Other | Part 1: Design and development |
Primary outcome
Safety and adverse events (AEs).
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jose Rauh-Hain, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interviews in people with ACT-GEN and Genetic Cancer Syndromes, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose Rauh-Hain, MD (713-794-1759, jarauh@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs). (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.