NCT05649072

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable ovarian-cancer

Timeline
8mo left

Started Nov 2022

Typical duration for not_applicable ovarian-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Nov 2022Feb 2027

Study Start

First participant enrolled

November 18, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2027

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

4.2 years

First QC Date

November 23, 2022

Last Update Submit

May 19, 2026

Conditions

Outcome Measures

Primary Outcomes (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.

Study Arms (2)

Genetic Testing and Counseling

OTHER

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

Screening Form

OTHER

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

Behavioral: Screening Form

Interventions

Participants will be asked to collect a saliva sample for hereditary cancer and genetic testing

Genetic Testing and Counseling
Screening FormBEHAVIORAL

Participant will be answering demographic details

Screening Form

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsBreast NeoplasmsColorectal Neoplasms

Interventions

Genetic TestingCounseling

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health ServicesMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health Services

Study Officials

  • Arun Banu, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2022

First Posted

December 13, 2022

Study Start

November 18, 2022

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations