Breast CancerNCT05916378
Achieving Equity in Genomic Testing for Breast Cancer Through Partner-Led Strategies and Policies
An observational study of Breast Cancer, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to identify the barriers, and the extent of said barriers, to genomic testing for breast cancer patients among low-income and minority populations, particularly throughout Northern California. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Breast Cancer
- How many people
- 514 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2023to 21 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We expect to recruit 150 participants for enrollment in phase 1. These participants will include 100 patients diagnosed with breast cancer and 50 caregivers. In phase 2, we expect to recruit 55 of our phase 1 survey participants to complete a one-time one-on-one in-depth interview.
Who may be able to join
- The patients must be 18 years or older.
- Patients who opt in to complete the survey.
- Patients must have the capacity to verbally consent for the interview.
Who cannot join
- Patients who under the age of 18 years old.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The purpose of this study is to identify the barriers, and the extent of said barriers, to genomic testing for breast cancer patients among low-income and minority populations, particularly throughout Northern California. The investigators have created a survey that is available online for any patient with cancer to fill out voluntarily regarding their experiences to date. The survey is available at: https://stanforduniversity.qualtrics.com/jfe/form/SV_7VElf8oesWcB3bE
Read the detailed description
The study has two main data-collecting phases. In phase 1, the investigators will engage multilevel stakeholders to respond to a survey assessing experience with and perceptions of genomic testing and its accessibility for patients with breast cancer in California. In phase 2, selected and interested survey participants who voluntarily provide their contact information on the survey will be asked to participate in an in-depth 1:1 semi-structured interview to explore disparities in genomic testing for breast cancer more closely. The investigators will then utilize their findings from both phases to present aggregate findings to an Expert Panel and Community Advisory Board and work together to develop policy recommendations. The policy recommendations will then be presented to policy makers, with the aim of identifying sustainable solutions that address breast cancer treatment and outcome disparities throughout Northern California.
- Conditions
- Breast Cancer
- Keywords
- Genomic Testing, Precision Breast Cancer Care, Precision Medicine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients and Caregivers | We will survey 100 patients and 50 caregivers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who fill out the survey and participate in the semi-structured interviews. [ Time Frame: 12 Months ]
We will track the number of participants who fill out the survey for the 12 month duration of the study and the number of participants who participate in the semi-structured telephone interviews.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start22 May 2023
- Primary completion15 Jul 2025
- Study completion21 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- The Latino Cancer Institute
- Responsible party
- Principal investigator, Manali Indravadan Patel, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916378
- Sponsor's protocol ID
- 68742
- Status last verified
- Apr 2026
- First submitted
- 14 Jun 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mary Umahi Obasi et al. Achieving equity in genomic testing for breast cancer through partner-led strategies and policies.. J Clin Oncol 43, 11027-11027(2025). DOI:10.1200/JCO.2025.43.16_suppl.11027
Olomu MUO, Scherer C, Wood E, Escobar K, Moufarrej S, Kamran R, Muir S, Munoz F, Stern M, Gomez S, Blayney DW, Chew H, Tealer LM, Alanes A, Moorehead D, Sanchez M, Sanchez KB, Tinianov S, Duron Y, Patel MI. Assessing barriers to genomic testing in breast cancer among diverse patients: a qualitative community-engaged research study. Breast Cancer Res Treat. 2025 Dec 29;215(2):47. doi: 10.1007/s10549-025-07871-8.
PubMed 41460588
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Equity in Genomic Testing for Breast Cancer Through Partner-Led Strategies and Policies
- ClinicalTrials.gov ID
- NCT05916378
- Acronym / sponsor ID
- 68742
- Conditions
- Breast Cancer
- Keywords
- Genomic Testing, Precision Breast Cancer Care, Precision Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- The Latino Cancer Institute
- Study start
- 22 May 2023 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 21 Apr 2026 (actual)
- First posted
- 23 Jun 2023 (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.
The purpose of this study is to identify the barriers, and the extent of said barriers, to genomic testing for breast cancer patients among low-income and minority populations, particularly throughout Northern California. The investigators have created a survey that is available online for any patient with cancer to fill out voluntarily regarding their experiences to date. The survey is available at: https://stanforduniversity.qualtrics.com/jfe/form/SV_7VElf8oesWcB3bE
Detailed description
The study has two main data-collecting phases. In phase 1, the investigators will engage multilevel stakeholders to respond to a survey assessing experience with and perceptions of genomic testing and its accessibility for patients with breast cancer in California. In phase 2, selected and interested survey participants who voluntarily provide their contact information on the survey will be asked to participate in an in-depth 1:1 semi-structured interview to explore disparities in genomic testing for breast cancer more closely. The investigators will then utilize their findings from both phases to present aggregate findings to an Expert Panel and Community Advisory Board and work together to develop policy recommendations. The policy recommendations will then be presented to policy makers, with the aim of identifying sustainable solutions that address breast cancer treatment and outcome disparities throughout Northern California.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients and Caregivers | – | –We will survey 100 patients and 50 caregivers. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We expect to recruit 150 participants for enrollment in phase 1. These participants will include 100 patients diagnosed with breast cancer and 50 caregivers. In phase 2, we expect to recruit 55 of our phase 1 survey participants to complete a one-time one-on-one in-depth interview.
Key inclusion criteria (3 listed)
- The patients must be 18 years or older.
- Patients who opt in to complete the survey.
- Patients must have the capacity to verbally consent for the interview.
Key exclusion criteria (1 listed)
- Patients who under the age of 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants who fill out the survey and participate in the semi-structured interviews. [ Time Frame: 12 Months ]
Time frame: 12 Months
We will track the number of participants who fill out the survey for the 12 month duration of the study and the number of participants who participate in the semi-structured telephone interviews.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- BackgroundMary Umahi Obasi et al. Achieving equity in genomic testing for breast cancer through partner-led strategies and policies.. J Clin Oncol 43, 11027-11027(2025). DOI:10.1200/JCO.2025.43.16_suppl.11027
- Results publication: PubMed 41460588Olomu MUO, Scherer C, Wood E, Escobar K, Moufarrej S, Kamran R, Muir S, Munoz F, Stern M, Gomez S, Blayney DW, Chew H, Tealer LM, Alanes A, Moorehead D, Sanchez M, Sanchez KB, Tinianov S, Duron Y, Patel MI. Assessing barriers to genomic testing in breast cancer among diverse patients: a qualitative community-engaged research study. Breast Cancer Res Treat. 2025 Dec 29;215(2):47. doi: 10.1007/s10549-025-07871-8.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Stanford University 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 30 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who fill out the survey and participate in the semi-structured interviews. [ Time Frame: 12 Months ] (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05916378, which also lists 2 linked publications.
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 30 Apr 2026.