Ultrasound Based Triaging of Women With Breast Lump on Clinical Breast Examination: A Pilot Study, Indonesia, 2025-28
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Positive predictive value and negative predictive value of CBE by ultrasound triaging
研究概览
简要总结
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.
详细描述
The project nested in the national breast cancer screening programme of Indonesia aims to determine whether ultrasound-based triaging by trained medical officers at primary health facilities can detect benign lesions in women with breast lumps identified through clinical breast examination (CBE) at these facilities. This point-of-care approach would help reduce the load on tertiary facilities at radiology and pathology centers and also prevent unnecessary interventions in women diagnosed with benign breast lesions in a CBE-based screening programme.
Primary Objective
- To determine the positive and negative predictive value of clinical breast examination in detecting malignancies when ultrasound-based triaging is performed by trained medical officers on women found positive through clinical breast examination Secondary objectives
- To determine the sensitivity and specificity of ultrasound-based triaging by trained medical officers at primary health centres by excluding the benign masses in breast
- To assess the outcomes of ultrasound-based triaging through early follow up screening of the women excluded from undergoing further evaluation
- To assess the feasibility and acceptability of taking up ultrasound-based triaging by trained medical officers at primary health centres as part of routine breast cancer screening pathway
Methods:
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
All women detected with a breast lump on clinical breast examination, who have consented for study
The identified women will be subject to ultrasound triaging, and those with non-cystic lesions will be referred for further evaluation
干预措施: Portable ultrasound device (Diagnostic Test)
结局指标
主要结局
Positive predictive value and negative predictive value of CBE by ultrasound triaging
时间窗: From recruitment to 30 months
次要结局
未报告次要终点
研究者
Ravivarman Lakshmanasamy
Public Heatlh Officer
International Agency for Research on Cancer