Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: US-guided breast biopsy, Ultrasound-guided breast biopsy training program.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Nigeria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure US-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. - Other 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
Primary outcome measures
- Accuracy of US-guided breast biopsy in Nigeria compared to reference standard surgical excision [Time frame: 12 months]
Secondary outcome measures (1)
- Complication rates from US-guided breast biopsy compared to reference values reported in the literature. [Time frame: 12 months]
Eligibility criteria
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
- Participants unwilling to sign consent
- Participants under the age of 18.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Nigeria · 1 center
- Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC) — Ile-Ife
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 PMID 40250340
Identifiers
NCT: NCT04501419 · ERC/2019/10/05 · 18-114