Ignite Creation Date:
2024-07-17 @ 11:18 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481930
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-25
Brief Title:
A Multicenter Real-world Study of Screening of Cervical Cancer Based on Photoelectric Detection
Sponsor:
Lei Li
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
A Multicenter Real-world Study of Screening of Cervical Cancer Based on Photoelectric Detection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 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 20000 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 Chinas national conditions
This study is expected to include 20000 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 Chinas national conditions
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