Trials / Not Yet Recruiting
Not Yet RecruitingNCT06481930
A Multicenter Real-world Study of Screening of Cervical Cancer Based on Photoelectric Detection
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 20,000 (estimated)
- Sponsor
- Lei Li · Academic / Other
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-07-01
- Primary completion
- 2026-07-01
- Completion
- 2026-07-01
- First posted
- 2024-07-01
- Last updated
- 2024-07-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06481930. Inclusion in this directory is not an endorsement.