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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with a solid mass on breast ultrasound | Participants will have a solid mass on breast ultrasound that is suspicious for breast cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mHealth US-breast biopsy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Sutton, MD | Contact | 646-888-5455 | suttone@mskcc.org | |
| Yolana Bryce, MD | Contact | 212-639-6530 | brycey@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Eliabeth Sutton, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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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| Lagos University Teaching Hospital | Recruiting | Idi-Araba | Lagos | Nigeria |
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| Olabisis Onabanjo University Teaching Hospital (Data Collection Only) | Active, not recruiting | Sagamu | Ogun State | Nigeria |
| Federal Medical Centre Owo (Data Collection Only) | Recruiting | Owo | Ondo State | Nigeria |
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| University College Hospital (Data Collection Only) | Active, not recruiting | Ibadan | Oyo State | Nigeria |
| University Of Nigeria Teaching Hospital (UNTH) Ituku-Ozalla Enugu | Recruiting | Enugu | Nigeria |
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| Obafemi Awolowo University Teaching Hospitals Complex (Data Collection Only) | Recruiting | Ile-Ife | Nigeria |
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| University of Ilorin Teaching Hospitals | Active, not recruiting | Ilorin | Nigeria |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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