Breast CancerNCT04501419
Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria
A study testing US-guided breast biopsy and Ultrasound-guided breast biopsy training program in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in Nigeria.
Trial summary
The purpose of this study is to train Nigerian radiologists to perform ultrasound-guided breast biopsies on women that present to the hospital with a suspicious breast mass. Before performing biopsies on patients, the Nigerian radiologists will have already successfully completed a competency-based mobile health… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- US-guided breast biopsy and Ultrasound-guided breast biopsy training program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteNigeria
- Study dates
- 5 Oct 2019to 30 Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 and older female
- Breast ultrasound demonstrating a solid mass that is suspicious for cancer, which would typically undergo either a blind biopsy or surgical excision at the Nigerian hospital where the patient is seeking diagnosis.
Who cannot join
- Participants unwilling to sign consent
- Participants under the age of 18.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nigeria1 site, 1 recruiting
- Recruiting
Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC)
Ile-Ife
Adeleye Omisore, MD, +2348031538004, omisoreadeleye@yahoo.com
About this study
The purpose of this study is to train Nigerian radiologists to perform ultrasound-guided breast biopsies on women that present to the hospital with a suspicious breast mass. Before performing biopsies on patients, the Nigerian radiologists will have already successfully completed a competency-based mobile health ultrasound-guided breast biopsy-training program. This program, developed by experts in Nigeria and the United States of America, certifies that they have the skills required to safely perform these biopsies on patients.
- Conditions
- Breast Cancer
- Being tested
- US-guided breast biopsy, Ultrasound-guided breast biopsy training program
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-guided breast biopsyProcedure or surgery
During this study, women with undergo an US-guided breast biopsy by a radiologist instead of what is typically performed in Nigerian hospitals, which is either a blind biopsy or surgical excision. US-guided breast biopsy is the standard of care in the United States of America because the accuracy is better than blind biopsy and equal to surgical excision.
Ultrasound-guided breast biopsy training programOther
This program, developed by experts in Nigeria and the United States of America, certifies that they have the skills required to safely perform these biopsies on patients
| Study group | Role | What they receive |
|---|---|---|
| Trained radiologists | Experimental | Trainers will successfully train Nigerian radiologists Receives: Other: Ultrasound-guided breast biopsy training program |
| Patients with a suspicious breast mass | Experimental | Women that present to the hospital with a suspicious breast mass Receives: Procedure: US-guided breast biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of US-guided breast biopsy in Nigeria compared to reference standard surgical excision
US-guided breast biopsies accuracy measurements will be reported using surgical pathology as the reference standard. Specifically we will report accuracy, positive predictive value, negative predictive value, sensitivity and specificity.
Measured: 12 months
Secondary outcomes (1)
Complication rates from US-guided breast biopsy compared to reference values reported in the literature.
To determine if the complication rate of US-guided breast biopsies performed by the trained Nigerian radiologists is equivalent to reference values reported in the literature.
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 posted6 Aug 2020
- Study start5 Oct 2019
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Memorial Sloan Kettering 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Obafemi Awolowo University Teaching Hospital
- Responsible party
- Sponsor
- Investigators
- Adeleye Omisore, MD, Principal investigator, Obafemi Awolowo University Teaching Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501419
- Sponsor's protocol ID
- ERC/2019/10/05
- Other IDs
- 18-114
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2020
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Publications
Omisore AD, Egberongbe AA, Pace LE, Raza S, Akinola RA, Obajimi MO, Sevilimedu V, Bryce Y, Mango VL, Alatise OI, Kingham TP, Morris EA, Sutton EJ. A Competency-Based Ultrasound-Guided Breast Biopsy Training Program for Radiologists From Low-and-Middle-Income Countries that Leverages Mobile Health Technology (NCT04501419): A Study Protocol. Cancer Control. 2025 Jan-Dec;32:10732748251334435. doi: 10.1177/10732748251334435. Epub 2025 Apr 18.
PubMed 40250340
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria
- ClinicalTrials.gov ID
- NCT04501419
- Acronym / sponsor ID
- ERC/2019/10/05
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Obafemi Awolowo University Teaching Hospital
- Study start
- 5 Oct 2019 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Aug 2020 (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 train Nigerian radiologists to perform ultrasound-guided breast biopsies on women that present to the hospital with a suspicious breast mass. Before performing biopsies on patients, the Nigerian radiologists will have already successfully completed a competency-based mobile health ultrasound-guided breast biopsy-training program. This program, developed by experts in Nigeria and the United States of America, certifies that they have the skills required to safely perform these biopsies on patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trained radiologists | Experimental | Other: Ultrasound-guided breast biopsy training programTrainers will successfully train Nigerian radiologists |
| Patients with a suspicious breast mass | Experimental | Procedure: US-guided breast biopsyWomen that present to the hospital with a suspicious breast mass |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 and older female
- Breast ultrasound demonstrating a solid mass that is suspicious for cancer, which would typically undergo either a blind biopsy or surgical excision at the Nigerian hospital where the patient is seeking diagnosis.
Key exclusion criteria (2 listed)
- Participants unwilling to sign consent
- Participants under the age of 18.
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 |
|---|---|---|
| US-guided breast biopsyDuring this study, women with undergo an US-guided breast biopsy by a radiologist instead of what is typically performed in Nigerian hospitals, which is either a blind biopsy or surgical excision. US-guided breast biopsy is the standard of care in the United States of America because the accuracy is better than blind biopsy and equal to surgical excision. | Procedure or surgery | Patients with a suspicious breast mass |
| Ultrasound-guided breast biopsy training programThis program, developed by experts in Nigeria and the United States of America, certifies that they have the skills required to safely perform these biopsies on patients | Other | Trained radiologists |
Primary outcome
Accuracy of US-guided breast biopsy in Nigeria compared to reference standard surgical excision
Time frame: 12 months
US-guided breast biopsies accuracy measurements will be reported using surgical pathology as the reference standard. Specifically we will report accuracy, positive predictive value, negative predictive value, sensitivity and specificity.
1 secondary outcome
Complication rates from US-guided breast biopsy compared to reference values reported in the literature.
Time frame: 12 months
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 27 Aug 2026.
- Derived from this study: PubMed 40250340Omisore AD, Egberongbe AA, Pace LE, Raza S, Akinola RA, Obajimi MO, Sevilimedu V, Bryce Y, Mango VL, Alatise OI, Kingham TP, Morris EA, Sutton EJ. A Competency-Based Ultrasound-Guided Breast Biopsy Training Program for Radiologists From Low-and-Middle-Income Countries that Leverages Mobile Health Technology (NCT04501419): A Study Protocol. Cancer Control. 2025 Jan-Dec;32:10732748251334435. doi: 10.1177/10732748251334435. Epub 2025 Apr 18.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Adeleye Omisore, MD principal investigator
Obafemi Awolowo University Teaching Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US-guided breast biopsy and Ultrasound-guided breast biopsy training program in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in Nigeria.
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 2 inclusion and 2 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 27 Aug 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 Nigeria. 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 Adeleye Omisore, MD (+2348031538004, omisoreadeleye@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of US-guided breast biopsy in Nigeria compared to reference standard surgical excision (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 NCT04501419, which also lists 1 linked publication.
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 27 Aug 2026.