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

NCT06481930 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20000

Last updated 2024-07-03

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Lei Li

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06481930 on ClinicalTrials.gov