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

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ClinicalTrials.gov Identifier: NCT00343213
Recruitment Status : Unknown
Verified August 2011 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : June 22, 2006
Last Update Posted : August 30, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Grade 1 (CIN 1) Procedure: colposcopy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources




Primary Outcome Measures :
  1. p16INK4a staining pattern and HPV status of the initial biopsy

Secondary Outcome Measures :
  1. p16INK4a staining pattern and histologic diagnosis of follow-up biopsies correlated with colposcopic findings.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
Responsible women > 18 years with histologically proven CIN 1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 22, 2006    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011

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

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