A Multicenter Randomized Controlled Study of Fluorescence Photoelectric Cervical Lesion Image Detector in Cervical Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4,200
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of a fluorescence photoelectric image detector for cervical lesions.
研究概览
简要总结
The main purpose of this study is to verify the accuracy of the fluorescence photoelectric cervical lesion image detector relative to the pathological gold standard and the detection rate of CIN 2 +, as well as the significance of it as a shunt tool before colposcopy through a randomized controlled study.
The secondary objectives were to compare the relative pathological accuracy of the fluorescence photoelectric cervical lesion image detection results with the HPV detection results and cytological results, and to compare the lesion area displayed by the fluorescence photoelectric cervical lesion image detector with the lesion area that appeared after traditional colposcopy chemical staining.
In this study, 4200 subjects who have been evaluated and can be enrolled (these subjects have the indication of referral to colposcopy) will be included in the study, and they will be divided into two groups according to the principle of randomization. The histological results were obtained after routine colposcopy and biopsy. The experimental group first underwent colposcopy and biopsy after the judgment of the fluorescent photoelectric cervical lesion image detector to obtain histological results. Finally, the accuracy of the relative pathological results, the detection rate of CIN2 +, negative predictive value and positive predictive value of the two groups were compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •1. Age ≥ 18 years old, ≤ 65 years old, with a complete cervix without deformity.
- •2. Have clear cervical cancer screening results, meet HPV16/18 (+) or high-risk HPV (+), and cervical cytology results ≥ ASC-US.
- •3. Fully informed and agreed to participate in the study.
- •4. No history of cervical cancer disease and cancer in other parts.
排除标准
- •1. Cannot meet all Inclusion Criteria.
- •2. There is clear immunosuppression, such as HIV infection or organ transplantation, etc., and the vagina or cervix is in the acute inflammation stage。
- •3. There are serious bleeding diseases or photosensitive diseases such as abnormal coagulation.
研究组 & 干预措施
Group Accepting Photoelectric Detection
The subjects in this group need to undergo the detection of fluorescence photoelectric cervical lesion image detector before colposcopy, and then undergo routine colposcopy and biopsy after the detection.
干预措施: Detection of Cervical Lesions by Fluorescence Photoelectric Image (Diagnostic Test)
Routine colposcopy group
Subjects who entered this group underwent colposcopy and biopsy according to the routine gynecological examination procedure.
结局指标
主要结局
Sensitivity and specificity of a fluorescence photoelectric image detector for cervical lesions.
时间窗: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.
Sensitivity and specificity of the fluorescence photoelectric detection technique relative to histopathological findings.
Detection rate of CIN2+ by fluorescence photoelectric cervical lesion image detector.
时间窗: Enrolled subjects receive histopathological results approximately 7 days after colposcopy.
The sensitivity, specificity, CIN2+ detection rate, negative predictive value and positive predictive value were compared between the fluorescence photoelectric technology and HPV detection results and cytology results, and the consistency and coincidence between the fluorescence photoelectric technology and HPV detection results and cytology results were calculated.
次要结局
- The correlation between fluorescence photoelectric technology and HPV detection and cytology results.(Enrolled subjects receive histopathological results approximately 7 days after colposcopy.)
研究者
Lei Li
Chief physician
Peking Union Medical College Hospital