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

NCT07407153 | Recruiting

• 1 other identifier: IARC IEC 25-12
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

breast; breast carcinoma; triage; ultrasound; portable device

Outcome Measures

Primary Outcomes (1)

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

  From recruitment to 30 months

Study Arms (1)

All women detected with a breast lump on clinical breast examination, who have consented for study

EXPERIMENTAL

The identified women will be subject to ultrasound triaging, and those with non-cystic lesions will be referred for further evaluation

Diagnostic Test: Portable ultrasound device

Interventions

Portable ultrasound device DIAGNOSTIC_TEST

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

All women detected with a breast lump on clinical breast examination, who have consented for study

Eligibility Criteria

• Age: 30 Years - 69 Years
• Gender Eligibility Details: Women eligible for breast cancer screening in the study site country
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Agency for Research on Cancer: lead
• Dharmais National Cancer Center Hospital: collaborator

Study Sites (1)

Dharmais hospital

Jakarta, West Jakarta, 11420, Indonesia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Public Heatlh Officer

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

ID (1)