We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00343213
Recruitment Status : Unknown
Verified August 2011 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : June 22, 2006
Last Update Posted : August 30, 2011
Sponsor:
Information provided by:

June 21, 2006
June 22, 2006
August 30, 2011
June 2006
Not Provided
p16INK4a staining pattern and HPV status of the initial biopsy
Same as current
Complete list of historical versions of study NCT00343213 on ClinicalTrials.gov Archive Site
p16INK4a staining pattern and histologic diagnosis of follow-up biopsies correlated with colposcopic findings.
Same as current
Not Provided
Not Provided
 
Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix.
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.
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 outcome.The 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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Prevention
Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)
Procedure: colposcopy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
300
Not Provided
Not Provided
Responsible women > 18 years with histologically proven CIN 1
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00343213
3454
Not Provided
Not Provided
Not Provided
Christine GEILLER, Directeur de la Recherche Clinique et des Innovations, Hôpitaux Universitaires de Strasbourg
University Hospital, Strasbourg, France
Not Provided
Study Director: Jean-Jacques Baldauf, MD Département de Gynécologie-Obstétrique - Hôpital de Hautepierre - Strasbourg - France
University Hospital, Strasbourg, France
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP