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

NCT ID: NCT00343213

Last Updated: 2011-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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colposcopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Responsible women \> 18 years with histologically proven CIN 1
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Hôpitaux Universitaires de Strasbourg

Principal Investigators

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Jean-Jacques Baldauf, MD

Role: STUDY_DIRECTOR

Département de Gynécologie-Obstétrique - Hôpital de Hautepierre - Strasbourg - France

Locations

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Service de Gynécologie-Obstétrique - Centre Hospitalier Général

Haguenau, , France

Site Status RECRUITING

Service de gynécologie-obtétrique - Centre Hospitalier Général

Saverne, , France

Site Status RECRUITING

Département de Gynécologie-Obstétrique - Hôpital de Hautepierre

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-Jacques Baldauf, MD

Role: CONTACT

3.33.88.12.74.59

Gerlinde Averous

Role: CONTACT

3.33.88.12.70.52

Facility Contacts

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Dominique Collin, MD

Role: primary

3.33.88.06.30.67

Jean-Luc Harter, MD

Role: primary

3.33.88.71.65.17

Jean-Jacques Baldauf, MD

Role: primary

3.33.88.12.74.59

Other Identifiers

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3454

Identifier Type: -

Identifier Source: org_study_id

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