Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04650711
Status:
UNKNOWN
Last Update Posted:
2020-12-03
First Post:
2020-11-25
Brief Title:
Immunohistochemical Staining of p16 for the Screening of Cervical Cancer
Sponsor:
Lei Li
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Immunohistochemical Staining of p16 for the Screening of Cervical Cancer
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
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:
Cyclin kinase inhibitor P16INK4A has overexpression in cervical cancer and hence becoming an alternative method for cervical cancer screening This study is to investigate the clinical value of P16INK4A and high-risk human papillomavirus hrHPV detection of cervical intraepithelial neoplasia CIN 2 or more severe lesions CIN2 All eligible participants accept P16INK4A testing with cytology andor hrHPV assay P16INK4A immunohistochemical staining is performed on the retained specimens of cytology The primary endpoint is the diagnostic accuracy of P16INK4A compared with cytology andor hrHPV status based on histology results The accuracy analysis includes sensitivity specificity negative predictive value and positive predictive value
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