Trials / Not Yet Recruiting
Not Yet RecruitingNCT06491888
A Multicenter Randomized Controlled Study of Photoelectric Detection in Cervical Cancer Screening
A Multicenter Randomized Controlled Study of Fluorescence Photoelectric Cervical Lesion Image Detector in Cervical Cancer Screening
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 4,200 (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 verify the accuracy of the fluorescence photoelectric cervical lesion image detector relative to the pathological gold standard and the detection rate of CIN 2 +, as well as the significance of it as a shunt tool before colposcopy through a randomized controlled study. The secondary objectives were to compare the relative pathological accuracy of the fluorescence photoelectric cervical lesion image detection results with the HPV detection results and cytological results, and to compare the lesion area displayed by the fluorescence photoelectric cervical lesion image detector with the lesion area that appeared after traditional colposcopy chemical staining. In this study, 4200 subjects who have been evaluated and can be enrolled (these subjects have the indication of referral to colposcopy) will be included in the study, and they will be divided into two groups according to the principle of randomization. The histological results were obtained after routine colposcopy and biopsy. The experimental group first underwent colposcopy and biopsy after the judgment of the fluorescent photoelectric cervical lesion image detector to obtain histological results. Finally, the accuracy of the relative pathological results, the detection rate of CIN2 +, negative predictive value and positive predictive value of the two groups were compared.
Conditions
- Uterine Cervical Cancer
- Cervical Intraepithelial Neoplasia
- High Grade Squamous Intraepithelial Lesions
- Low Grade Squamous Intraepithelial Lesions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Detection of Cervical Lesions by Fluorescence Photoelectric Image | Photoelectric detection was carried out on the subjects of the experimental group. |
Timeline
- Start date
- 2024-08-01
- Primary completion
- 2025-07-01
- Completion
- 2025-07-01
- First posted
- 2024-07-09
- Last updated
- 2024-08-15
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06491888. Inclusion in this directory is not an endorsement.