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New program aims to boost family communication about genetic risks

NCT ID NCT07318363

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study tests a program to help people with certain genetic mutations share their results with at-risk relatives and make informed decisions about genetic testing and care. About 2100 adults in the U.S. who speak English or Spanish will take part. The program provides free genetic counseling and testing, plus support for family communication.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 2,100 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Apr 2032

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Inclusion Criteria: Probands: 1. 18 years of age or older 2. Speaks and reads English or Spanish 3. Resides in the United States 4. Has a pathogenic or suspected pathogenic variant in BRCA1, BRCA2, MLH1, MSH2/EPCAM, MSH6, or PMS2\* 5. Has access to the internet or phone and can send and receive email and/or text messages at a US telephone number. 6. Attests to have at least one at-risk relative who meets inclusion criteria for first-degree relative * For cancer patients who are unaware of their mutation status, we will share existing local and national genetics resources, like those provided in the usual care family letter. At-Risk Relatives (ARR): 1. 18 years of age or older 2. Speaks and reads English or Spanish 3. Resides in the United States 4. Has a first or second degree relative who has a deleterious/suspected deleterious HBOC or LS variant present 5. Has access to internet or phone and can send and receive email and/or text messages at a US telephone number SAB: 1\. Eligible SAB will include any groups connected to HBOC or Lynch syndrome, including those that focus on underserved populations or specific ethnic communities. Clinicians: 1\. Eligible clinicians will include gynecologic oncologists, general gynecologists, medical oncologists, and advanced practice providers who interact with individuals diagnosed with HBOC or Lynch syndrome and/or their at-risk relatives. Exclusion Criteria: Probands: 1. Has no eligible at-risk relatives (ARRs) or is unable/unwilling to provide their contact information 2. Has negative germline genetic testing or only variant of uncertain significance 3. Unwilling or unable to provide consent At-Risk Relatives (ARR): 1. Unwilling or unable to provide consent 2. Reports no known HBOC or LS variant within the family 3. Has already been tested for the variant identified in the proband 4. Already listed as an ARR for another proband SAB: 1\. SAB members will be excluded if they are not connected to HBOC or Lynch syndrome-related groups or if their organizations do not focus on these conditions or the communities impacted by them. Clinicians: 1\. Clinicians will be excluded if they do not provide direct care to individuals diagnosed with HBOC or Lynch syndrome or their at-risk relatives, or if they do not practice within the specified eligible clinician roles.

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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

  • The University of Texas M. D. Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

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