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


Trial Overview

StatusConditionSponsor/Collaborator(s)First ReceivedLast ChangedVerification Date
Recruiting Cervical Intraepithelial Neoplasia Grade 1 (CIN 1) University Hospital, Strasbourg, France Other June 21, 2006 August 29, 2011 August 2011

Study TypeStudy DesignPhaseEnrollmentStart DateEnd 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

FacilityAddressContactPhoneEmailStatus
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

TypeInterventionDescription
Procedure colposcopy -

Outcome

TypeMeasureTime FrameSafety 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

GenderMinimum AgeMaximum AgeHealthy Volunteers
Female - N/A No

Responsible women > 18 years with histologically proven CIN 1