A Multicenter Randomized Controlled Study of Photoelectric Detection in Cervical Cancer Screening
NCT Number: NCT06491888
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Uterine Cervical Cancer|Cervical Intraepithelial Neoplasia|High Grade Squamous Intraepithelial Lesions|Low Grade Squamous Intraepithelial Lesions
Interventions: DIAGNOSTIC_TEST: Detection of Cervical Lesions by Fluorescence Photoelectric Image
Sponsor: Lei Li
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 4200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-08
Completion Date: 2025-07
Locations: Lei Li, Beijing, Beijing, 100730, China

Summary:
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.

Primary Outcome Measures: Sensitivity and specificity of a fluorescence photoelectric image detector for cervical lesions., Sensitivity and specificity of the fluorescence photoelectric detection technique relative to histopathological findings., Enrolled subjects receive histopathological results approximately 7 days after colposcopy.|Detection rate of CIN2+ by fluorescence photoelectric cervical lesion image detector., 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., Enrolled subjects receive histopathological results approximately 7 days after colposcopy.
Secondary Outcome Measures: The correlation between fluorescence photoelectric technology and HPV detection and cytology results., The sensitivity, specificity, CIN2+ detection rate, negative predictive value and positive predictive value were compared with the results of HPV detection and cytology., Enrolled subjects receive histopathological results approximately 7 days after colposcopy.