- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05694559
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
August 7, 2026 updated by: M.D. Anderson Cancer Center
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Banu Arun, MD
- Phone Number: 713-792-2817
- Email: barun@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- MD Anderson Cancer Center
-
Contact:
- Banu Arun, MD
- Phone Number: 713-792-2817
- Email: barun@mdanderson.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Genetic Testing and Counseling
Participants will be given a saliva collection kit to collect a saliva sample for hereditary cancer and genetic testing.
|
Participants will complete testing
|
|
Experimental: 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:
|
Participants will complete forms with demographics and history
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
genetic risk screening tool (GRST) questionnaire
Time Frame: through study completion; an average of 1 year.
|
through study completion; an average of 1 year.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Banu Arun, MD, MD Anderson Cancer Cneter
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 23, 2022
Primary Completion (Estimated)
February 2, 2027
Study Completion (Estimated)
February 2, 2027
Study Registration Dates
First Submitted
January 12, 2023
First Submitted That Met QC Criteria
January 20, 2023
First Posted (Actual)
January 23, 2023
Study Record Updates
Last Update Posted (Actual)
August 10, 2026
Last Update Submitted That Met QC Criteria
August 7, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Skin Diseases
- Breast Diseases
- Skin and Connective Tissue Diseases
- Colorectal Neoplasms
- Breast Neoplasms
- Investigative Techniques
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Health Services
- Health Care Facilities Workforce and Services
- Community Health Services
- Preventive Health Services
- Behavioral Disciplines and Activities
- Mental Health Services
- Genetic Techniques
- Genetic Services
- Diagnostic Services
- Genetic Testing
- Counseling
Other Study ID Numbers
- 2022-0328
- NCI-2023-00252 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.