Breast Cancer
Conditions
Brief summary
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.
Interventions
PROCEDUREUS-guided breast biopsy
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.
OTHERUltrasound-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
Sponsors
Memorial Sloan Kettering Cancer Center
Obafemi Awolowo University Teaching Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of US-guided breast biopsy in Nigeria compared to reference standard surgical excision | 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
| Measure | Time frame | Description |
|---|---|---|
| Complication rates from US-guided breast biopsy compared to reference values reported in the literature. | 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. |
Countries
Nigeria
Contacts
CONTACTAdeleye Omisore, MD
CONTACTElizabeth Sutton, MD
PRINCIPAL_INVESTIGATORAdeleye Omisore, MD
Obafemi Awolowo University Teaching Hospitals
Outcome results
None listed