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Mobile Health Ultrasound for Breast Cancer Diagnosis in Nigeria

This study is looking at a new way to diagnose breast cancer in Nigeria using a procedure called US-guided breast biopsy (ultrasound-guided breast biopsy). This method uses ultrasound to guide the biopsy, which is a standard practice in the United States. The study aims to train Nigerian radiologists to perform these biopsies using mobile health (mHealth) devices. You may be able to join if you are an adult woman (18 years or older) with a breast ultrasound showing a solid mass that doctors suspect might be cancer. The main goal is to see how many successful US-guided breast biopsies are performed over one year. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 900 women. It is not specified if it's randomized or blinded.
What's involved
If you participate, you will undergo an US-guided breast biopsy performed by a trained radiologist.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, successful US-guided breast biopsies, will be measured at 1 year.

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NCT05561842

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)

Recruiting
Not specifiedAges 18+Observational
Memorial Sloan Kettering Cancer Center
~900 participants
Updated 2025-10-14 on ClinicalTrials.gov
What's tested:mHealth US-breast biopsy

At a glance

Recruiting sites
5 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of successful US-guided breast biopsy
Measured over 1 year

Conditions

Breast Cancer
Breast Cancer Female

Explore related trials

Breast Carcinoma

Where it's being run

8 sites across 6 states
Nigeria3
New York1
Lagos1
Ogun State1
Ondo State1
Oyo State1

Study leadership

  • Eliabeth Sutton, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Elizabeth Sutton, MD
[email protected]
646-888-5455
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Participants unwilling to sign consent.
Participants under the age of 18.

What this trial measures

  • Number of successful US-guided breast biopsy1 year

    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.