Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria
2 other identifiers
interventional
600
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Oct 2019
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 5, 2019
CompletedFirst Submitted
Initial submission to the registry
August 3, 2020
CompletedFirst Posted
Study publicly available on registry
August 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
August 12, 2025
August 1, 2025
6.7 years
August 3, 2020
August 11, 2025
Conditions
Outcome Measures
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.
12 months
Secondary Outcomes (1)
Complication rates from US-guided breast biopsy compared to reference values reported in the literature.
12 months
Study Arms (2)
Trained radiologists
EXPERIMENTALTrainers will successfully train Nigerian radiologists
Patients with a suspicious breast mass
EXPERIMENTALWomen that present to the hospital with a suspicious breast mass
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Participants unwilling to sign consent
- Participants under the age of 18.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC)
Ile-Ife, Nigeria
Related Publications (1)
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.
PMID: 40250340DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adeleye Omisore, MD
Obafemi Awolowo University Teaching Hospitals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2020
First Posted
August 6, 2020
Study Start
October 5, 2019
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
August 12, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
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.