Portable ultrasound to sort breast lumps found on clinical exam
Official title: Ultrasound Based Triaging of Women With Breast Lump on Clinical Breast Examination: A Pilot Study, Indonesia, 2025-28
Run by International Agency for Research on Cancer · NCT07407153 · Data updated 2026-11-12
This project will try using a hand-held ultrasound at primary clinics to see if trained medical officers can separate likely-benign breast lumps from those needing more tests in women who have a lump on clinical breast exam.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 30 Years to 69 Years |
| Sex | Women only |
| Enrollment | 600 (estimated) |
| Sponsor | International Agency for Research on Cancer Academic / other |
| Locations | 1 site (Jakarta, West Jakarta) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | February 28, 2028 |
| Study ends | April 30, 2028 |
| Registry record updated | February 12, 2026 |
| Trial ID | NCT07407153 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women eligible for the national breast screening program who are found to have a breast lump on clinical breast examination, can provide informed consent, and are likely to comply with study follow-up are ideal candidates.
✕Probably not a fit
Women with recent screening within three years, a known history of breast cancer or breast surgery, clear high-probability cancer symptoms, debilitating illness, or inability to consent are excluded and unlikely to benefit from this triage approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Nested in Indonesia's national breast screening program, this prospective project trains medical officers at primary health facilities to use a hand-held ultrasound to triage women with lumps found on clinical breast examination. Women with lumps will be classified as likely benign or potentially malignant at the point of care, with benign cases avoiding immediate referral for mammography or biopsy. The study will measure predictive values, sensitivity and specificity of the ultrasound-based triage, follow early outcomes of those spared further evaluation, and assess feasibility and acceptability of the approach. The goal is to reduce workload at tertiary radiology and pathology centers and limit unnecessary procedures for women with benign lesions.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary mammograms and biopsies and lower the burden on tertiary centers while preserving timely care for women with suspicious lumps.
How similar studies have gone: Hand-held ultrasound for characterizing breast lumps has shown promise in prior studies, but using trained medical officers at primary-care sites for formal triage is less well studied and still being validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Dharmais hospital
Jakarta, West Jakarta, Indonesia Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.