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| Sponsor: | University Hospital, Strasbourg, France |
|---|---|
| Information provided by: | University Hospital, Strasbourg, France |
| ClinicalTrials.gov Identifier: | NCT00343213 |
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: | Prevention, Non-Randomized, Double-Blind, Historical Control, Factorial Assignment, Efficacy Study |
| 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. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Responsible women > 18 years with histologically proven CIN 1
Contacts and Locations| 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 |
| France | |
| 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 | |
| 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 | |
| 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 | |
| Study Director: | Jean-Jacques Baldauf, MD | Département de Gynécologie-Obstétrique - Hôpital de Hautepierre - Strasbourg - France |
More Information
| Responsible Party: | Hôpitaux Universitaires de Strasbourg ( Christine GEILLER, Directeur de la Recherche Clinique et des Innovations ) |
| Study ID Numbers: | 3454 |
| Study First Received: | June 21, 2006 |
| Last Updated: | November 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00343213 History of Changes |
| Health Authority: | France: Ministry of Health |
|
Prognostic value of p16INK4a CIN 1 LSIL HPV |
|
Genital Diseases, Female Uterine Cervical Diseases Neoplasms Neoplasms by Histologic Type Precancerous Conditions Carcinoma in Situ |
Uterine Diseases Uterine Cervical Dysplasia Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |