Evaluation of a Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Health Workers and Medical Officers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Accuracy of non-radiologist portable ultrasound device for triaging women with positive clinical breast examination
研究概览
简要总结
Cross sectional study to evaluate estimate accuracy of portable ultrasound device in correctly differentiating the benign breast lesions from the malignant ones in the women referred with a positive Clinical breast examination (CBE) screening test.
详细描述
More than two million new cases of breast cancer occur each year worldwide. Implementing mammography screening is complex and resource-intensive, making it impractical in resource-limited settings. Clinical breast examination (CBE) has been recommended as an alternative screening option for low- and middle-income countries. Several studies have shown a significant shift towards earlier stage tumours detected by CBE. However, the high false-positive rate and low positive predictive value of CBE expose women to unnecessary and costly further diagnostic procedures, as well as the negative psychological consequences. There is an urgent need for a more accurate, cost-effective and reliable triage technology that can be performed by any healthcare provider.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Clinical breast examination positive women with no debilitating illness.
- •Symptomatic women found to be positive on clinical breast examination by nurses/midwives or medical officers.
排除标准
- •Women with confirmed diagnosis of breast cancer or those already treated for the disease.
结局指标
主要结局
Accuracy of non-radiologist portable ultrasound device for triaging women with positive clinical breast examination
时间窗: Through study completion, an average of 1 year
Sensitivity, specificity and positive and negative predictive values of portable ultrasound device to detect breast cancer and carcinoma in situ with repeat clinical breast examination, mammography/ultrasound and/or cytology/core biopsy as the gold standard test.
次要结局
- Agreement between portable ultrasound device and mammography/ultrasound(Through study completion, an average of 1 year)
研究者
Farida Selmouni
Scientist
International Agency for Research on Cancer