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

Not Applicable

• Conditions: Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)

• Registration Number: NCT00343213
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-21
• Study First Submitted QC: 2006-06-21
• Study First Posted: 2006-06-22
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-29
• Last Update Posted: 2011-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
p16INK4a staining pattern and HPV status of the initial biopsy

Secondary Outcome Measures

Name	Time	Method
p16INK4a staining pattern and histologic diagnosis of follow-up biopsies correlated with colposcopic findings.

Trial Locations

Locations (3)

Département de Gynécologie-Obstétrique - Hôpital de Hautepierre; 🇫🇷 Strasbourg, France

Service de gynécologie-obtétrique - Centre Hospitalier Général; 🇫🇷 Saverne, France

Service de Gynécologie-Obstétrique - Centre Hospitalier Général; 🇫🇷 Haguenau, France