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| ID | Type | Description | Link |
|---|---|---|---|
| 18-114 | Other Identifier | Memorial Sloan Kettering Cancer Center |
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| Name | Class |
|---|---|
| Obafemi Awolowo University Teaching Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trained radiologists | Experimental | Trainers will successfully train Nigerian radiologists |
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| Patients with a suspicious breast mass | Experimental | Women that present to the hospital with a suspicious breast mass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of US-guided breast biopsy in Nigeria compared to reference standard surgical excision | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rates from US-guided breast biopsy compared to reference values reported in the literature. | 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Breast cancer
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adeleye Omisore, MD | Contact | +2348031538004 | omisoreadeleye@yahoo.com | |
| Elizabeth Sutton, MD | Contact | 646-888-5455 | suttone@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Adeleye Omisore, MD | Obafemi Awolowo University Teaching Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC) | Recruiting | Ile-Ife | Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40250340 | Derived | Omisore AD, Egberongbe AA, Pace LE, Raza S, Akinola RA, Obajimi MO, Sevilimedu V, Bryce Y, Mango VL, Alatise OI, Kingham TP, Morris EA, Sutton EJ. A Competency-Based Ultrasound-Guided Breast Biopsy Training Program for Radiologists From Low-and-Middle-Income Countries that Leverages Mobile Health Technology (NCT04501419): A Study Protocol. Cancer Control. 2025 Jan-Dec;32:10732748251334435. doi: 10.1177/10732748251334435. Epub 2025 Apr 18. |
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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.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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 |
|
| D017437 |
| Skin and Connective Tissue Diseases |