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Identifying Underserved Individuals inTexas With Hereditary Cancer Risk Using Mobile Mammography Units and Telegenetics.

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05649072
Collaborator
Community Outreach and Engagement Fund for Underserved Texans (Other)
1,000
Enrollment
1
Location
2
Arms
6.4
Anticipated Duration (Months)
156.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Identifying women at risk for hereditary cancer potentiates prevention, early detection or personalised treatment against cancer. We using mobile mammography units will provide genetic sceening and testing services to underserved women coming for thier mammograms to these units.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Genetic Testing and Counseling
  • Behavioral: Screening Form
 N/A

Detailed Description

Objectives:

  1. To identify underserved women at risk for hereditary breast and colorectal cancers and would be eligible for standard of care genetic counseling and testing using national screening guidelines.

  2. To provide education to providers and patients regarding hereditary cancers using previously IRB approved educational material and short video.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Identifying Underserved Individuals inTexas With Hereditary Cancer Risk Using Mobile Mammography Units and Telegenetics.
Actual Study Start Date :
Nov 18, 2022
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Genetic Testing and Counseling

Participants will be given a saliva collection kit to collect a saliva sample for hereditary cancer and genetic testing. The kit includes all standard paperwork and instructions for collecting the sample and shipping the kit back to the genetic testing company (Invitae).

Behavioral: Genetic Testing and Counseling
Participants will be asked to collect a saliva sample for hereditary cancer and genetic testing
Other: Screening Form

Participants will complete a screening form to assess your risk of hereditary breast and colorectal cancers.

Behavioral: Screening Form
Participant will be answering demographic details

Outcome Measures

Primary Outcome Measures

  1. To identify underserved women at risk for hereditary breast and colorectal cancers eligible for standard-of-care genetic counseling using national screening guidelines. [through study completion; an average of 1 year.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Any woman scheduled at Project VALET mammography screening mobile units will be eligible for this study.

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 M D Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • M.D. Anderson Cancer Center
  • Community Outreach and Engagement Fund for Underserved Texans

Investigators

  • Principal Investigator: Arun Banu, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT05649072
Other Study ID Numbers:
  • 2022-0329
  • NCI-2022-10036
First Posted:
Dec 13, 2022
Last Update Posted:
Dec 13, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 13, 2022