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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

Primary Purpose

Breast Cancer, Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Genetic Testing and Counseling
Screening Form
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Genetic Testing and Counseling

Screening Form

Arm Description

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

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

Outcomes

Primary Outcome Measures

genetic risk screening tool (GRST) questionnaire

Secondary Outcome Measures

Full Information

First Posted
January 12, 2023
Last Updated
August 14, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05694559
Brief 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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2022 (Actual)
Primary Completion Date
February 2, 2027 (Anticipated)
Study Completion Date
February 2, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Genetic Testing and Counseling
Arm Type
Experimental
Arm Description
Participants will be given a saliva collection kit to collect a saliva sample for hereditary cancer and genetic testing.
Arm Title
Screening Form
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Genetic Testing and Counseling
Intervention Description
Participants will complete testing
Intervention Type
Behavioral
Intervention Name(s)
Screening Form
Intervention Description
Participants will complete forms with demographics and history
Primary Outcome Measure Information:
Title
genetic risk screening tool (GRST) questionnaire
Time Frame
through study completion; an average of 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Banu Arun, MD
Phone
713-792-2817
Email
barun@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Banu Arun, MD
Organizational Affiliation
MD Anderson Cancer Cneter
Official's Role
Principal Investigator
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Banu Arun, MD
Phone
713-792-2817
Email
barun@mdanderson.org

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

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

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