Evaluation of modified thermography as a tool for early detection of breast cancer in women attending breast clinic at NICPR
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Sensitivity, specificity, negative and positive predictive values of Thermalytix® with mammography and/or cytology/core biopsy as the gold standard verification test
研究概览
简要总结
Primary Objective:
To estimate the sensitivity, specificity and predictive values of Thermalytix© in detecting breast cancers in the women attending breast clinic at NICPR against the age appropriate ‘gold-standard’ test USG/mammography and/or tissue diagnosis.
Methodology
The proposed study will be a prospective, comparative and blinded study to evaluate the effectiveness of the Thermalytix© when compared to the standard screening modalities in subjects.
All subjects who arrive at the breast clinic will be first made to go through non-invasive Thermalytix® test, followed by clinical breast examination. Thermalytix® will be performed in a separate room assigned for it by a technician who is trained in performing this procedure. Women who are found to be suspicious of breast abnormalities in either of the tests are sent to mammography and sonomammography correlation. All the results will be tabulated by an independent trial co-ordinator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged between 30 to 65 years attending breast clinic at NICPR will be included.
排除标准
- •Pregnant women
- •Lactating women
- •Women diagnosed with breast cancer
- •Women not able to provide consent.
结局指标
主要结局
Sensitivity, specificity, negative and positive predictive values of Thermalytix® with mammography and/or cytology/core biopsy as the gold standard verification test
时间窗: At the end of one year
次要结局
- 1. The agreement between the Thermalytix® and ultrasound/mammography diagnosis(2.Improvement in the PPV of CBE by Thermalytix® triaging)