Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix.
Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)
Conditions: official terms
Carcinoma in Situ - Cervical Intraepithelial Neoplasia - Uterine Cervical Dysplasia
Conditions: Keywords
Prognostic value of p16INK4a, CIN 1, LSIL, HPV
Study Type
Study Phase
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Name: colposcopy
Type: Procedure
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Responsible women > 18 years with histologically proven CIN 1
Service de Gynécologie-Obstétrique - Centre Hospitalier Général
Haguenau, France
Status: Recruiting
Contact: Dominique Collin, MD - - dominique.collin@ch-haguenau.fr
Service de gynécologie-obtétrique - Centre Hospitalier Général
Saverne, France
Status: Recruiting
Contact: Jean-Luc Harter, MD - - jeanluc.harter@ch-saverne.fr
Département de Gynécologie-Obstétrique - Hôpital de Hautepierre
Strasbourg, France
Status: Recruiting
Contact: Jean-Jacques Baldauf, MD - - jean-jacques.baldauf@chru-strasbourg.fr
Start Date
June 2006
University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page