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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00343213
First received: June 21, 2006
Last updated: August 29, 2011
Last verified: August 2011
  Purpose

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 Intervention
Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)
Procedure: colposcopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

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.

Estimated Enrollment: 300
Study Start Date: June 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Responsible women > 18 years with histologically proven CIN 1

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343213

Contacts
Contact: Jean-Jacques Baldauf, MD 3.33.88.12.74.59 jean-jacques.baldauf@chru-strasbourg.fr
Contact: Gerlinde Averous 3.33.88.12.70.52 gerlinde.averous@chru-strasbourg.fr

Locations
France
Service de Gynécologie-Obstétrique - Centre Hospitalier Général Recruiting
Haguenau, France
Contact: Dominique Collin, MD    3.33.88.06.30.67    dominique.collin@ch-haguenau.fr   
Service de gynécologie-obtétrique - Centre Hospitalier Général Recruiting
Saverne, France
Contact: Jean-Luc Harter, MD    3.33.88.71.65.17    jeanluc.harter@ch-saverne.fr   
Département de Gynécologie-Obstétrique - Hôpital de Hautepierre Recruiting
Strasbourg, France, 67098
Contact: Jean-Jacques Baldauf, MD    3.33.88.12.74.59    jean-jacques.baldauf@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Study Director: Jean-Jacques Baldauf, MD Département de Gynécologie-Obstétrique - Hôpital de Hautepierre - Strasbourg - France
  More Information

No publications provided

Responsible Party: Christine GEILLER, Directeur de la Recherche Clinique et des Innovations, Hôpitaux Universitaires de Strasbourg
ClinicalTrials.gov Identifier: NCT00343213     History of Changes
Other Study ID Numbers: 3454
Study First Received: June 21, 2006
Last Updated: August 29, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
Prognostic value of p16INK4a
CIN 1
LSIL
HPV

Additional relevant MeSH terms:
Uterine Cervical Dysplasia
Neoplasms
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 17, 2014