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

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT00343213

Collaborator

(none)

300

Enrollment

Locations

100

Patients Per Site

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)	Procedure: colposcopy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Masking:

Double

Primary Purpose:

Prevention

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.

Study Start Date :

Jun 1, 2006

Outcome Measures

Primary Outcome Measures

p16INK4a staining pattern and HPV status of the initial biopsy []

Secondary Outcome Measures

p16INK4a staining pattern and histologic diagnosis of follow-up biopsies correlated with colposcopic findings. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Responsible women > 18 years with histologically proven CIN 1

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Service de Gynécologie-Obstétrique - Centre Hospitalier Général	Haguenau	France
2	Service de gynécologie-obtétrique - Centre Hospitalier Général	Saverne	France
3	Département de Gynécologie-Obstétrique - Hôpital de Hautepierre	Strasbourg	France	67098