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

NCT ID: NCT06481930

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 20000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2026-07-31

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.

Conditions

Uterine Cervical Cancer; High Grade Squamous Intraepithelial Lesions; Low Grade Squamous Intraepithelial Lesions

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

The cervical lesion was detected by fluorescence photoelectricity in the enrolled patients

The enrolled patients were detected with fluorescence photoelectric cervical lesion image detector.

Detection of Cervical Lesions by Fluorescence Photoelectric Image

Intervention Type: DIAGNOSTIC_TEST

The enrolled patients underwent fluorescence photoelectric cervical lesion image detection, followed by colposcopy and biopsy to obtain histopathological results. The results of fluorescence photoelectric image detection were compared with histopathological results, and at the same time compared with HPV and TCT results at the time of enrollment.

Interventions

Detection of Cervical Lesions by Fluorescence Photoelectric Image

The enrolled patients underwent fluorescence photoelectric cervical lesion image detection, followed by colposcopy and biopsy to obtain histopathological results. The results of fluorescence photoelectric image detection were compared with histopathological results, and at the same time compared with HPV and TCT results at the time of enrollment.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lei Li

OTHER

Sponsor Role: lead

Responsible Party

Lei Li

Chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Lei Li

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Lei Li, M.D.

Role: CONTACT

lileigh@163.com

8613911988831

Other Identifiers

K5505

Identifier Type: -

Identifier Source: org_study_id