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

NCT00343213 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2011-08-30

No results posted yet for this study

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.

Conditions

  • Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)

Interventions

PROCEDURE

colposcopy

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Jean-Jacques Baldauf, MD · Département de Gynécologie-Obstétrique - Hôpital de Hautepierre - Strasbourg - France

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00343213 on ClinicalTrials.gov