About this trial
This study aims to stratify women diagnosed with a lump in the breast by clinical breast examination(CBE) using a hand-held ultrasound machine. They will be stratified either with benign or potentially malignant lesion. As most of the lesions identified by CBE are benign, stratifying them (triage) avoids the unnecessary procedures in terms of mammography and biopsy. This will also reduce the burden in the further assessment sites, and provide better quality services in these places.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women eligible for breast cancer screening as per the National screening programme in the country, and those detected with a breast lump on clinical breast examination
Disqualifiers
Women already screened in the last three years
Women with known history of breast cancer or breast surgery
Symptomatic with high probability of breast cancer diagnosis (ulcerated lump, blood-stained nipple discharge etc.)
Debilitating illness
Trial design
Single group
Treatments tested in this trial
Portable ultrasound device
Diagnostic testThe women detected with a breast lump on clinical breast examination will be examined using a portable ultrasound device by a trained medical officer at the primary healthcare facility, to traige them
Treatment groups
Trial outcomes
Primary outcomes
Positive predictive value and negative predictive value of CBE by ultrasound triaging
Sponsors and contacts
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International Agency for Research on Cancer
Lead sponsor
Dharmais National Cancer Center Hospital
Collaborator