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)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Participants unwilling to sign consent.

Participants under the age of 18.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • mHealth US-breast biopsy

    Procedure/Surgery

    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.

Treatment groups

900 Participants
are divided into 1 treatment group
Group A: Participants with a solid mass on breast ultrasound1 intervention

Trial outcomes

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.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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