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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mHealth US-breast biopsy.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Breast Cancer Female. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Nigeria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria
Overview
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.
Interventions
- 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.
Primary outcome measures
- Number of successful US-guided breast biopsy [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Nigeria · 7 centers
- Lagos University Teaching Hospital — Idi-Araba
- Olabisis Onabanjo University Teaching Hospital (Data Collection Only) — Sagamu
- Federal Medical Centre Owo (Data Collection Only) — Owo
- University College Hospital (Data Collection Only) — Ibadan
- University Of Nigeria Teaching Hospital (UNTH) Ituku-Ozalla Enugu — Enugu
- Obafemi Awolowo University Teaching Hospitals Complex (Data Collection Only) — Ile-Ife
- University of Ilorin Teaching Hospitals — Ilorin
United States · 1 center
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
Identifiers
NCT: NCT05561842 · 21-325