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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04501419
• Other study ID #: ERC/2019/10/05
• Secondary ID: 18-114
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Adeleye Omisore, MD
• Phone: +2348031538004
• Email: omisoreadeleye[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Nigeria	Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC)	Ile-Ife

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Obafemi Awolowo University Teaching Hospital

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 months