Spots Global Cancer Trial Database for Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Non-radiologists

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Trial Identification

Brief Title: Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Non-radiologists

Official Title: Evaluation of a Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Health Workers and Medical Officers

Study ID: NCT06056843

Conditions

Breast Cancer

Carcinoma in Situ

Interventions

Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists.

Study Description

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.