Triaging of Women Detected With a Breast Lump on Clinical Breast Examination Using Portable Ultrasound Device
Recruiting · NCT07407153 · Interventional (participants receive a specific treatment) · Lead sponsor: International Agency for Research on Cancer
View the official record on ClinicalTrials.gov →Interventions studied
Portable ultrasound device
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.
Who can take part
Age range
30 Years to 69 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Dharmais hospital - Jakarta, West Jakarta, Indonesia