Actively Recruiting

Phase Not Applicable
Age: 30Years - 69Years
FEMALE
NCT07407153

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

Led by International Agency for Research on Cancer · Updated on 2026-02-12

600

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

Sponsors

I

International Agency for Research on Cancer

Lead Sponsor

D

Dharmais National Cancer Center Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 30Years - 69Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Dharmais hospital

Jakarta, West Jakarta, Indonesia, 11420

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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