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.
Brief Title
Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
+2348031538004
Central Contact Email
omisoreadeleye@yahoo.com
Central Contact Role
Contact
Central Contact Phone
646-888-5455
Central Contact Email
suttone@mskcc.org
Completion Date
Completion Date Type
Estimated
Conditions
Breast Cancer
Eligibility Criteria
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.
* 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.
Inclusion Criteria
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.
* 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.
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04501419
Org Class
Other
Org Full Name
Memorial Sloan Kettering Cancer Center
Org Study Id
ERC/2019/10/05
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria
Primary Outcomes
Outcome Description
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.
Outcome Measure
Accuracy of US-guided breast biopsy in Nigeria compared to reference standard surgical excision
Outcome Time Frame
12 months
Secondary Ids
Secondary Id
18-114
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
12 months
Outcome Measure
Complication rates from US-guided breast biopsy compared to reference values reported in the literature.
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Dean Hosgood
Investigator Email
dean.hosgood@einsteinmed.org
Investigator Phone