Evaluation of a Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Health Workers and Medical Officers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- International Agency for Research on Cancer
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Accuracy of non-radiologist portable ultrasound device for triaging women with positive clinical breast examination
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Cross sectional study to evaluate estimate accuracy of portable ultrasound device in correctly differentiating the benign breast lesions from the malignant ones in the women referred with a positive Clinical breast examination (CBE) screening test.
Detailed Description
More than two million new cases of breast cancer occur each year worldwide. Implementing mammography screening is complex and resource-intensive, making it impractical in resource-limited settings. Clinical breast examination (CBE) has been recommended as an alternative screening option for low- and middle-income countries. Several studies have shown a significant shift towards earlier stage tumours detected by CBE. However, the high false-positive rate and low positive predictive value of CBE expose women to unnecessary and costly further diagnostic procedures, as well as the negative psychological consequences. There is an urgent need for a more accurate, cost-effective and reliable triage technology that can be performed by any healthcare provider.
Investigators
Farida Selmouni
Scientist
International Agency for Research on Cancer
Eligibility Criteria
Inclusion Criteria
- •Clinical breast examination positive women with no debilitating illness.
- •Symptomatic women found to be positive on clinical breast examination by nurses/midwives or medical officers.
Exclusion Criteria
- •Women with confirmed diagnosis of breast cancer or those already treated for the disease.
Outcomes
Primary Outcomes
Accuracy of non-radiologist portable ultrasound device for triaging women with positive clinical breast examination
Time Frame: Through study completion, an average of 1 year
Sensitivity, specificity and positive and negative predictive values of portable ultrasound device to detect breast cancer and carcinoma in situ with repeat clinical breast examination, mammography/ultrasound and/or cytology/core biopsy as the gold standard test.
Secondary Outcomes
- Agreement between portable ultrasound device and mammography/ultrasound(Through study completion, an average of 1 year)