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

NCT06481930 | Not Yet Recruiting

• 1 other identifier: K5505
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Accuracy of tissue lesion screening based on photoelectric detection

  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.

  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.

Study Arms (1)

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

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

Diagnostic Test: Detection of Cervical Lesions by Fluorescence Photoelectric Image

Interventions

Detection of Cervical Lesions by Fluorescence Photoelectric Image 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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a multicenter, parallel controlled, cross-sectional real-world study based on the population of a hospital gynecology clinic (gynecology clinic/colposcopy room).

You may qualify if:

• \. Age ≥ 18 years old, ≤ 65 years old, with a complete cervix without deformity.
• \. Have clear cervical cancer screening results, meet HPV16/18 (+) or high-risk HPV (+), and cervical cytology results ≥ ASC-US.
• \. Fully informed and agreed to participate in the study.
• \. No history of cervical cancer disease and cancer in other parts.

You may not qualify if:

• \. There is clear immunosuppression, such as HIV infection or organ transplantation, etc., and the vagina or cervix is in the acute inflammation stage。
• \. There are serious bleeding diseases or photosensitive diseases such as abnormal coagulation.

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lei Li, M.D.

CONTACT

8613911988831; lileigh@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-06

Locations

CN (1)