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Recruiting

NCT Number: NCT04501419

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 on women that present to the hospital with a suspicious breast mass. Before performing biopsies on patients, the Nigerian radiologists will have already successfully completed a competency-based mobile health ultrasound-guided breast biopsy-training program. This program, developed by experts in Nigeria and the United States of America, certifies that they have the skills required to safely perform these biopsies on patients.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC)

Ile-Ife, Nigeria

Location status: Recruiting

Location contact

Adeleye Omisore, MD

CONTACT

[email protected]

+2348031538004

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

US-guided breast biopsy

Procedure

During this study, women with 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.

Ultrasound-guided breast biopsy training program

Other

This program, developed by experts in Nigeria and the United States of America, certifies that they have the skills required to safely perform these biopsies on patients

Primary outcomes

  1. Accuracy of US-guided breast biopsy in Nigeria compared to reference standard surgical excision

    Time frame: 12 months

    US-guided breast biopsies accuracy measurements will be reported using surgical pathology as the reference standard. Specifically we will report accuracy, positive predictive value, negative predictive value, sensitivity and specificity.

Secondary outcomes

  1. Complication rates from US-guided breast biopsy compared to reference values reported in the literature.

    Time frame: 12 months

    To determine if the complication rate of US-guided breast biopsies performed by the trained Nigerian radiologists is equivalent to reference values reported in the literature.

Study contacts

Contact information is provided by the study sponsor or research team.

Adeleye Omisore, MD

CONTACT

[email protected]

+2348031538004

Elizabeth Sutton, MD

CONTACT

[email protected]

646-888-5455

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Obafemi Awolowo University Teaching Hospital

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2020
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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