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)
1 other identifier
observational
900
2 countries
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 21, 2022
CompletedFirst Submitted
Initial submission to the registry
September 27, 2022
CompletedFirst Posted
Study publicly available on registry
September 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 21, 2027
October 14, 2025
October 1, 2025
4 years
September 27, 2022
October 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Participants with a solid mass on breast ultrasound
Participants will have a solid mass on breast ultrasound that is suspicious for breast cancer.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Participants unwilling to sign consent.
- Participants under the age of 18.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Lagos University Teaching Hospital
Idi Araba, Lagos, Nigeria
Olabisis Onabanjo University Teaching Hospital (Data Collection Only)
Sagamu, Ogun State, Nigeria
Federal Medical Centre Owo (Data Collection Only)
Owo, Ondo State, Nigeria
University College Hospital (Data Collection Only)
Ibadan, Oyo State, Nigeria
University Of Nigeria Teaching Hospital (UNTH) Ituku-Ozalla Enugu
Enugu, Nigeria
Obafemi Awolowo University Teaching Hospitals Complex (Data Collection Only)
Ile-Ife, Nigeria
University of Ilorin Teaching Hospitals
Ilorin, Nigeria
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eliabeth Sutton, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2022
First Posted
September 30, 2022
Study Start
September 21, 2022
Primary Completion (Estimated)
September 21, 2026
Study Completion (Estimated)
September 21, 2027
Last Updated
October 14, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
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.