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

Lei Li

Status: Not yet enrolling

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

Treatments: Diagnostic Test: Detection of Cervical Lesions by Fluorescence Photoelectric Image

Study type: Observational

Funder types: Other

Identifiers

NCT06481930

K5505

Details and patient eligibility

About

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.

Enrollment: 20,000 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

20,000 participants in 1 patient group

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

Description:

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

Treatment:

Diagnostic Test: Detection of Cervical Lesions by Fluorescence Photoelectric Image