New program aims to boost family communication about genetic risks
NCT ID NCT07318363
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 2,100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2032
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
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