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

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Other: Ultrasound-guided breast biopsy training program; Procedure: US-guided breast biopsy

• Registration Number: NCT04501419
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2019-10-05
• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 600

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trained radiologists	Ultrasound-guided breast biopsy training program	Trainers will successfully train Nigerian radiologists
Patients with a suspicious breast mass	US-guided breast biopsy	Women that present to the hospital with a suspicious breast mass

Primary Outcome Measures

Name	Time	Method
Accuracy of US-guided breast biopsy in Nigeria compared to reference standard surgical excision	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.

Secondary Outcome Measures

Name	Time	Method
Complication rates from US-guided breast biopsy compared to reference values reported in the literature.	12 months	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.

Trial Locations

Locations (1)

Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC); 🇳🇬 Ile-Ife, Nigeria