A Multicenter Real-world Study of Screening of Cervical Cancer Based on Photoelectric Detection

Not yet recruiting

• Conditions: Low Grade Squamous Intraepithelial Lesions; Uterine Cervical Cancer; High Grade Squamous Intraepithelial Lesions
• Interventions: Diagnostic Test: Detection of Cervical Lesions by Fluorescence Photoelectric Image

• Registration Number: NCT06481930
• Lead Sponsor: Lei Li

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-06-25
• Last Update Submitted: 2024-06-30
• Study Start: 2024-07
• Study First Posted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20000

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: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The cervical lesion was detected by fluorescence photoelectricity in the enrolled patients	Detection of Cervical Lesions by Fluorescence Photoelectric Image	The enrolled patients were detected with fluorescence photoelectric cervical lesion image detector.

Primary Outcome Measures

Name	Time	Method
Accuracy of tissue lesion screening based on photoelectric detection	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.

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China