RecruitingNot Applicable

Triaging of Women Detected With a Breast Lump on Clinical Breast Examination Using Portable Ultrasound Device

Indonesia600 participantsStarted 2025-06-01

Plain-language 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.

Who can participate

Age range

30 Years – 69 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Positive predictive value and negative predictive value of CBE by ultrasound triaging

Timeframe: From recruitment to 30 months

Trial details

NCT IDNCT07407153

SponsorInternational Agency for Research on Cancer

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02-28

View on ClinicalTrials.gov More Breast Cancer trials