Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Portable ultrasound device | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All women detected with a breast lump on clinical breast examination, who have consented for study
- description
- The identified women will be subject to ultrasound triaging, and those with non-cystic lesions will be referred for further evaluation
- interventionNames
- Diagnostic Test: Portable ultrasound device
Primary outcomes (1)
- measure
- Positive predictive value and negative predictive value of CBE by ultrasound triaging
- timeFrame
- From recruitment to 30 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available