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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-69
SponsorInternational Agency for Research on Cancer

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: All women detected with a breast lump on clinical breast examination, who have consented for studyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From recruitment to 30 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

International Agency for Research on Cancer

Lead sponsor

Dharmais National Cancer Center Hospital

Collaborator