A Multicenter Randomized Controlled Study of Photoelectric Detection in Cervical Cancer Screening

Not Applicable

Not yet recruiting

• 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

• Registration Number: NCT06491888
• Lead Sponsor: Lei Li

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Study First Posted: 2024-07-09
• Status Verified: 2024-08
• Study Start: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 4200

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Accepting Photoelectric Detection	Detection of Cervical Lesions by Fluorescence Photoelectric Image	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of a fluorescence photoelectric image detector for cervical lesions.	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.	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.

Secondary Outcome Measures

Name	Time	Method
The correlation between fluorescence photoelectric technology and HPV detection and cytology results.	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 with the results of HPV detection and cytology.

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China