Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343213
Status:
UNKNOWN
Last Update Posted:
2011-08-30
First Post:
2006-06-21
Brief Title:
Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
Study Overview
Official Title:
Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix Immunohistochemical Study on Biopsies Retrospective and Prospective Analysis and on Liquid Based SurePath Cervical Cytology Prospective Analysis Correlation With HPV Typing and Clinical Outcome
Status:
UNKNOWN
Status Verified Date:
2011-08
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:
P16INK4a has recently been described as a surrogate marker for HR-HPV associated squamous and glandular intraepithelial lesions of the cervix The immunohistochemical staining pattern of p16INK4a in high grade intraepithelial neoplasia of the cervix CIN 2 and 3 is diffuse whereas in CIN 1 different staining patterns diffuse sporadic focal or negative can be seen The aim of our study is to find out whether the p16INK4a staining pattern of CIN 1 is able to predict the outcome of the lesion The retrospective part of the study includes cervical biopsies of 200 patients with CIN 1 and clinical follow-up for at least 5 years p16INK4a staining and HPV detection by IHC will be correlated to clinical outcomeThe prospective part of the study includes 300 patients with CIN 1 and LSIL on cytology HPV detection by HCII and p16INK4a immunohistochemistry on liquid based cytology samples as well as p16INK4a staining and HPV detection by ISH on colposcopy guided biopsies will be correlated to clinical follow-up and colposcopy findings Slides are analysed by 2 pathologists without knowledge of clinical data
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None