A Multicenter Real-world Study of Screening of Cervical Cancer Based on Photoelectric Detection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Accuracy of tissue lesion screening based on photoelectric detection
研究概览
简要总结
The main purpose of this study is to explore the accuracy and clinical value of fluorescent photoelectric cervical lesion image detector as a screening and shunt tool for cervical lesions through a multi-center, large-sample real-world study with histopathology as the gold standard. The secondary purpose of the study was to verify the coincidence of the fluorescent photoelectric cervical lesion image detector with traditional colposcopic chemical staining.
This study is expected to include 20,000 participants with definite histological results, and compare the specificity and sensitivity, negative predictive value and positive predictive value of three cervical lesion screening methods, such as fluorescent photoelectric cervical lesion image detector, HPV nucleic acid detection and cytology detection. The advantages and disadvantages of fluorescent photoelectric cervical disease image detector, HPV nucleic acid detection and cytology examination were analyzed, and their application scenarios were provided to provide evidence-based medical support for the establishment of comprehensive prevention and treatment system of cervical cancer suitable for China's national conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old, ≤ 65 years old, with a complete cervix without deformity.
- •Have clear cervical cancer screening results, meet HPV16/18 (+) or high-risk HPV (+), and cervical cytology results ≥ ASC-US.
- •Fully informed and agreed to participate in the study.
- •No history of cervical cancer disease and cancer in other parts.
排除标准
- •Cannot meet all Inclusion Criteria.
- •There is clear immunosuppression, such as HIV infection or organ transplantation, etc., and the vagina or cervix is in the acute inflammation stage。
- •There are serious bleeding diseases or photosensitive diseases such as abnormal coagulation.
结局指标
主要结局
Accuracy of tissue lesion screening based on photoelectric detection
时间窗: The data collection time for each subject is approximately 7 days, starting from the day of each subject's enrollment and ending when the pathology report of the cervical tissue biopsy under colposcopy is issued.
The sensitivity, specificity, positive predictive value and negative predictive value of fluorescence photoelectric cervix lesion image detector were calculated by using CIN 2 + as the gold standard determined by histopathology, and compared with those of HPV and TCT.
次要结局
未报告次要终点
研究者
Lei Li
Chief physician
Peking Union Medical College Hospital