Connecting Black Families in Houston, Texas to Hereditary Cancer Genetic Counseling, Genetic Testing, and Cascade Testing by Using a Simple Genetic Risk Screening Tool and Telegenetics

NCT ID: NCT05694559

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-23

Study Completion Date

2027-02-02

Brief Summary

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To identify Black individuals who are eligible for genetic testing through trusted community organizations, and to connect Black individuals and their families to genetic testing and counseling so that they can know their cancer risk and how to decrease it.

Detailed Description

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Primary Objectives:

* To identify 300 Black families, at least one individual per family, eligible for genetic testing using our validated simple genetic risk screening tool (GRST) 1, via collaboration with trusted community organizations. For individuals eligible for genetic testing, we will counsel them about genetic testing, including reviewing GRST results, explaining why they are eligible for genetic testing as part of standard-of-care, explaining what this entails, offering on-site or remote genetic testing, and explaining that they will be connected to a genetic counselor if they have a pathogenic mutation (PV) of a variant of unknown significance (VUS), including resources for family cascade genetic testing.
* To provide genetic testing to 150 Black individuals and families and provide genetic counseling and risk reduction resources to individuals with a PV or VUS, including cascade genetic testing for their family members.

Conditions

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Breast Cancer Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Genetic Testing and Counseling

Participants will be given a saliva collection kit to collect a saliva sample for hereditary cancer and genetic testing.

Group Type EXPERIMENTAL

Genetic Testing and Counseling

Intervention Type BEHAVIORAL

Participants will complete testing

Screening Form

Participants will complete a screening form to assess your risk of hereditary breast and colorectal cancers. You will be asked to provide your:

* Name and contact information (including your address, phone number, and email)
* Demographic information (including your age, race, and ethnicity)
* Health insurance status
* Annual household income
* Personal and family history of cancer, including diagnosis and age at diagnosis

Group Type EXPERIMENTAL

Screening Form

Intervention Type BEHAVIORAL

Participants will complete forms with demographics and history

Interventions

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Genetic Testing and Counseling

Participants will complete testing

Intervention Type BEHAVIORAL

Screening Form

Participants will complete forms with demographics and history

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Any participant over 18 years old who self-identifies as Black or African-American and signs an informed consent form, also referred to as the 'Permission to Contact' form, to be part of our study.

Exclusion Criteria

None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Banu Arun, MD

Role: PRINCIPAL_INVESTIGATOR

MD Anderson Cancer Cneter

Locations

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MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Banu Arun, MD

Role: CONTACT

713-792-2817

Facility Contacts

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Banu Arun, MD

Role: primary

713-792-2817

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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NCI-2023-00252

Identifier Type: REGISTRY

Identifier Source: secondary_id

2022-0328

Identifier Type: -

Identifier Source: org_study_id

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