New program aims to keep High-Risk cancer gene carriers on track with screenings
NCT ID NCT07565467
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Act-gen are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- The question after preventive mastectomy: would women do it again?
- A watchful eye: could alternating scans outsmart pancreatic cancer?
- Can a walking routine alter cancer biomarkers? new trial investigates
- Digital assistant aims to close gaps in hereditary cancer care
- Lynch syndrome patients share colonoscopy struggles in new survey
- Personalized vaccine aims to stop lynch syndrome cancers before they start