Triaging of Women Detected With a Breast Lump on Clinical Breast Examination Using Portable Ultrasound Device
Ultrasound Based Triaging of Women With Breast Lump on Clinical Breast Examination: A Pilot Study, Indonesia, 2025-28
International Agency for Research on Cancer
600 participants
Jun 1, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria1
- 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
Exclusion Criteria6
- 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
- Unable to provide informed consent due to certain mental illnesses
- Unlikely to be compliant to study procedures and/or follow up as determined by the investigator
Interventions
The 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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07407153