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Trial Title:
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
Condition:
Breast Cancer
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Genetic Testing and Counseling
Description:
Participants will complete testing
Arm group label:
Genetic Testing and Counseling
Intervention type:
Behavioral
Intervention name:
Screening Form
Description:
Participants will complete forms with demographics and history
Arm group label:
Screening Form
Summary:
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:
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Banu Arun, MD
Phone:
713-792-2817
Email:
barun@mdanderson.org
Start date:
November 23, 2022
Completion date:
February 2, 2027
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05694559
http://www.mdanderson.org
