RecruitingNot ApplicableNCT07407153

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

Sponsor

International Agency for Research on Cancer

Enrollment

600 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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

Sex: FEMALEMin Age: 30 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a portable handheld ultrasound device can be used to triage (quickly assess) women who have been found to have a breast lump during a routine clinical exam, potentially reducing unnecessary referrals and delays in care. **You may be eligible if...** - You are a woman eligible for breast cancer screening in your country's national program - A breast lump was found during your clinical breast examination **You may NOT be eligible if...** - You were screened for breast cancer in the last 3 years - You have a known history of breast cancer or prior breast surgery - You have symptoms that strongly suggest cancer (such as a bleeding nipple or an open wound) - You have a serious illness - You are unable to give informed consent - You are unlikely to follow up with study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPortable ultrasound device

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)

Dharmais hospital

Jakarta, West Jakarta, Indonesia

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NCT07407153

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