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RecruitingNCT04501419Updated Aug 27, 2026

Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria

An interventional study of US-guided breast biopsy and Ultrasound-guided breast biopsy training program in Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 1 site in Nigeria. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
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Study 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 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.

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Conditions studied

  • Breast Cancer

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Participants unwilling to sign consent
  • Participants under the age of 18.
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Trained radiologists

    Trainers will successfully train Nigerian radiologists

    Other: Ultrasound-guided breast biopsy training program

  • Experimental
    Patients with a suspicious breast mass

    Women that present to the hospital with a suspicious breast mass

    Procedure: US-guided breast biopsy

Interventions

  • ProcedureUS-guided breast biopsy

    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.

  • OtherUltrasound-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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 12 months

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Study locations

1 of 1 sites recruiting
  • Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC)
    Ile-Ife, Nigeria
    Recruiting
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References and documents

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 ↗

Individual participant data

Plan to share: 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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Registry details

Key details

Study ID
NCT04501419
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Obafemi Awolowo University Teaching Hospital
Responsible party
Sponsor
First posted
Aug 6, 2020
Start date
Oct 5, 2019
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Aug 27, 2026

Study contacts

Adeleye Omisore, MD
Contact
omisoreadeleye@yahoo.com
+2348031538004
Elizabeth Sutton, MD
Contact
suttone@mskcc.org
646-888-5455
Adeleye Omisore, MD
principal investigator · Obafemi Awolowo University Teaching Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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