Ignite Creation Date:
2024-07-17 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491888
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-01
Brief Title:
A Multicenter Randomized Controlled Study of Photoelectric Detection in Cervical Cancer Screening
Sponsor:
Lei Li
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
A Multicenter Randomized Controlled Study of Fluorescence Photoelectric Cervical Lesion Image Detector in Cervical Cancer Screening
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None