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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Ultrasound-guided breast biopsy training program; Procedure: US-guided breast biopsy

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adeleye Omisore, MD; Phone Number: +2348031538004; Email: omisoreadeleye@yahoo.com
• Study Contact Backup: Name: Elizabeth Sutton, MD; Phone Number: 646-888-5455; Email: suttone@mskcc.org

Study Locations

• Nigeria
  • Ile-Ife, Nigeria
    • Recruiting
    • Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC)
    • Contact: Adeleye Omisore, MD; Phone Number: +2348031538004; Email: omisoreadeleye@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trained radiologists; Trainers will successfully train Nigerian radiologists	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
Experimental: Patients with a suspicious breast mass; Women that present to the hospital with a suspicious breast mass	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Obafemi Awolowo University Teaching Hospital
• Investigators: Principal Investigator: Adeleye Omisore, MD, Obafemi Awolowo University Teaching Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2019
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ERC/2019/10/05; 18-114 (Memorial Sloan Kettering Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No