Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria (Mobile Health: Technology and Outcomes in Low and Middle-Income Countries)

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. Researchers will use mHealth devices to create a sustainable and practical way of training radiologists in Nigeria to perform and clinically implement US-guided breast biopsies into their practice.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Cancer Female
• Intervention / Treatment: Procedure: mHealth US-breast biopsy

• Study Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

• Study Contact: Name: Elizabeth Sutton, MD; Phone Number: 646-888-5455; Email: suttone@mskcc.org
• Study Contact Backup: Name: Yolana Bryce, MD; Phone Number: 212-639-6530; Email: brycey@mskcc.org

Study Locations

• Nigeria
  • Enugu, Nigeria
    • Recruiting
    • University Of Nigeria Teaching Hospital (UNTH) Ituku-Ozalla Enugu
    • Contact: Nneka Iloanusi, MD; Phone Number: 08033143023; Email: nneka.iloanusi@unn.edu.ng
  • Ile-Ife, Nigeria
    • Recruiting
    • Obafemi Awolowo University Teaching Hospitals Complex (Data Collection Only)
    • Contact: Adeleye Omisore, MD; Phone Number: +2348031538004; Email: omisoreadeleye@yahoo.com
  • Ilorin, Nigeria
    • Active, not recruiting
    • University of Ilorin Teaching Hospitals
  • Lagos
    • Idi-Araba, Lagos, Nigeria
      • Recruiting
      • Lagos University Teaching Hospital
      • Contact: Olubukola Omidiji, MD; Phone Number: 08122167403; Email: olubukolaomidiji@yahoo.com
  • Ogun State
    • Sagamu, Ogun State, Nigeria
      • Active, not recruiting
      • Olabisis Onabanjo University Teaching Hospital (Data Collection Only)
  • Ondo State
    • Owo, Ondo State, Nigeria
      • Recruiting
      • Federal Medical Centre Owo (Data Collection Only)
      • Contact: Adedeji Egberongbe, MD; Phone Number: 08034714382; Email: deji_egbe@yahoo.com
  • Oyo State
    • Ibadan, Oyo State, Nigeria
      • Active, not recruiting
      • University College Hospital (Data Collection Only)
• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All protocol activities)
      • Contact: Elizabeth Sutton, MD; Phone Number: 646-888-5455

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be accrued in medical clinics as determined by the local investigators and local research staff. Informed consent forms approved by each local IRB will be obtained by research staff from each site.

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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with a solid mass on breast ultrasound; Participants will have a solid mass on breast ultrasound that is suspicious for breast cancer.	Procedure: mHealth US-breast biopsy; During this study, women will 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
Number of successful US-guided breast biopsy	Trainees will be evaluated using a passing criterion of 80% on a validated test that assesses competency based on the The Ottawa Surgical Competency Operating Room Evaluation (O-Score). There are 8 variables rated on a scale of 1-5. A trainee will be given a passing grade if the responses on all 8 variables are 4 or 5 and this is achieved in at least 80% of the unsupervised simulation and patient biopsies.	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Eliabeth Sutton, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Estimated): September 21, 2026
• Study Completion (Estimated): September 21, 2027

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 10, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: breast cancer; Memorial Sloan Kettering Cancer Center; breast ultrasound; breast biopsy; breast cancer diagnosis; 21-325
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 21-325

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