Ovarian CancerNCT05649072
Identifying Underserved Individuals inTexas With Hereditary Cancer Risk Using Mobile Mammography Units and Telegenetics.
A study testing Genetic Testing and Counseling and Screening Form in people with Ovarian Cancer and Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Breast Cancer, Colorectal Cancer
- What is being tested?
- Genetic Testing and Counseling and Screening Form
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2022to 2 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any woman scheduled at Project VALET mammography screening mobile units will be eligible for this study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Arun Banu, MD, 713-792-2817, barun@mdanderson.org
Arun Banu, MD
About this study
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.
Read the detailed description
Objectives:
- 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.
- To provide education to providers and patients regarding hereditary cancers using previously IRB approved educational material and short video.
- Conditions
- Ovarian Cancer, Breast Cancer, Colorectal Cancer
- Being tested
- Genetic Testing and Counseling, Screening Form
- Medical subject headings
- Ovarian Neoplasms, Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic Testing and CounselingBehavioural
Participants will be asked to collect a saliva sample for hereditary cancer and genetic testing
Screening FormBehavioural
Participant will be answering demographic details
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Genetic Testing and Counseling |
| Screening Form | Other | Participants will complete a screening form to assess your risk of hereditary breast and colorectal cancers. Receives: Behavioral: Screening Form |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify underserved women at risk for hereditary breast and colorectal cancers eligible for standard-of-care genetic counseling using national screening guidelines.
Measured: through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start18 Nov 2022
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Community Outreach and Engagement Fund for Underserved Texans
- Responsible party
- Sponsor
- Investigators
- Arun Banu, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649072
- Sponsor's protocol ID
- 2022-0329
- Other IDs
- NCI-2022-10036
- Status last verified
- May 2026
- First submitted
- 23 Nov 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Underserved Individuals inTexas With Hereditary Cancer Risk Using Mobile Mammography Units and Telegenetics.
- ClinicalTrials.gov ID
- NCT05649072
- Acronym / sponsor ID
- 2022-0329
- Conditions
- Ovarian Cancer, Breast Cancer, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Community Outreach and Engagement Fund for Underserved Texans
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives:
- 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.
- To provide education to providers and patients regarding hereditary cancers using previously IRB approved educational material and short video.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genetic Testing and Counseling | Other | Behavioral: Genetic Testing and CounselingParticipants 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). |
| Screening Form | Other | Behavioral: Screening FormParticipants will complete a screening form to assess your risk of hereditary breast and colorectal cancers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any woman scheduled at Project VALET mammography screening mobile units will be eligible for this study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic Testing and CounselingParticipants will be asked to collect a saliva sample for hereditary cancer and genetic testing | Behavioural | Genetic Testing and Counseling |
| Screening FormParticipant will be answering demographic details | Behavioural | Screening Form |
Primary outcome
To identify underserved women at risk for hereditary breast and colorectal cancers eligible for standard-of-care genetic counseling using national screening guidelines.
Time frame: through study completion; an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arun Banu, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic Testing and Counseling and Screening Form in people with Ovarian Cancer and Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arun Banu, MD ((713) 792-2817, barun@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify underserved women at risk for hereditary breast and colorectal cancers eligible for standard-of-care genetic counseling using national screening guidelines. (time frame: through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.