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New program aims to keep High-Risk cancer gene carriers on track with screenings

NCT ID NCT07565467

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 25, 2026 · Updated 3 times

Summary

This study tests a program to help people with inherited cancer gene mutations (like BRCA or Lynch syndrome) stick to recommended cancer screening schedules. Researchers will interview 80 female participants and provide standard care to see if this approach improves adherence and reduces cancer risk. The goal is to lower the chance of developing cancer through better surveillance.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better ways to help people with genetic cancer risks stick to screening plans and catch cancer early.
What could go wrong
This is an early-stage study with only 80 participants, so results may not apply to everyone. It focuses on adherence, not directly preventing cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Mar 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

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Other studies related to the condition(s) this trial covers.