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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-05

Study Completion Date

2026-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Trained radiologists

Trainers will successfully train Nigerian radiologists

Group Type EXPERIMENTAL

Ultrasound-guided breast biopsy training program

Intervention Type OTHER

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

Patients with a suspicious breast mass

Women that present to the hospital with a suspicious breast mass

Group Type EXPERIMENTAL

US-guided breast biopsy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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

Intervention Type OTHER

Eligibility Criteria

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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.