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

Trial Overview

Status	Condition	Sponsor/Collaborator(s)	First Received	Last Changed	Verification Date
Recruiting	Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)	University Hospital, Strasbourg, France Other	June 21, 2006	August 29, 2011	August 2011

Study Type	Study Design	Phase	Enrollment	Start Date	End Date
Interventional	Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention	N/A	300	June 2006	-

Locations

Facility	Address	Contact	Phone	Email	Status
Service de Gynécologie-Obstétrique - Centre Hospitalier Général	Haguenau France	Dominique Collin, MD	-	dominique.collin@ch-haguenau.fr	Recruiting
Service de gynécologie-obtétrique - Centre Hospitalier Général	Saverne France	Jean-Luc Harter, MD	-	jeanluc.harter@ch-saverne.fr	Recruiting
Département de Gynécologie-Obstétrique - Hôpital de Hautepierre	Strasbourg 67098 France	Jean-Jacques Baldauf, MD	-	jean-jacques.baldauf@chru-strasbourg.fr	Recruiting

Intervention

Type	Intervention	Description
Procedure	colposcopy	-

Outcome

Type	Measure	Time Frame	Safety Issue
Primary	p16INK4a staining pattern and HPV status of the initial biopsy	-	-
Secondary	p16INK4a staining pattern and histologic diagnosis of follow-up biopsies correlated with colposcopic findings.	-	-

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

Gender	Minimum Age	Maximum Age	Healthy Volunteers
Female	-	N/A	No

Responsible women > 18 years with histologically proven CIN 1

Your Basket

Boliven PRO - The leading information portal for IP and patent search

Join today