Back to resultsDiagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix.
Primary Purpose
Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
colposcopy
Sponsored by
About this trial
This is an interventional prevention trial for Cervical Intraepithelial Neoplasia Grade 1 (CIN 1) focused on measuring Prognostic value of p16INK4a, CIN 1, LSIL, HPV
Eligibility Criteria
Responsible women > 18 years with histologically proven CIN 1
Sites / Locations
- Service de Gynécologie-Obstétrique - Centre Hospitalier GénéralRecruiting
- Service de gynécologie-obtétrique - Centre Hospitalier GénéralRecruiting
- Département de Gynécologie-Obstétrique - Hôpital de HautepierreRecruiting
Outcomes
Primary Outcome Measures
p16INK4a staining pattern and HPV status of the initial biopsy
Secondary Outcome Measures
p16INK4a staining pattern and histologic diagnosis of follow-up biopsies correlated with colposcopic findings.
Full Information
NCT ID
NCT00343213
First Posted
June 21, 2006
Last Updated
August 29, 2011
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT00343213
Brief Title
Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix.
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 Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)
Keywords
Prognostic value of p16INK4a, CIN 1, LSIL, HPV
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
colposcopy
Primary Outcome Measure Information:
Title
p16INK4a staining pattern and HPV status of the initial biopsy
Secondary Outcome Measure Information:
Title
p16INK4a staining pattern and histologic diagnosis of follow-up biopsies correlated with colposcopic findings.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Responsible women > 18 years with histologically proven CIN 1
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Jacques Baldauf, MD
Phone
3.33.88.12.74.59
Email
jean-jacques.baldauf@chru-strasbourg.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Gerlinde Averous
Phone
3.33.88.12.70.52
Email
gerlinde.averous@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques Baldauf, MD
Organizational Affiliation
Département de Gynécologie-Obstétrique - Hôpital de Hautepierre - Strasbourg - France
Official's Role
Study Director
Facility Information:
Facility Name
Service de Gynécologie-Obstétrique - Centre Hospitalier Général
City
Haguenau
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Collin, MD
Phone
3.33.88.06.30.67
Email
dominique.collin@ch-haguenau.fr
Facility Name
Service de gynécologie-obtétrique - Centre Hospitalier Général
City
Saverne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Luc Harter, MD
Phone
3.33.88.71.65.17
Email
jeanluc.harter@ch-saverne.fr
Facility Name
Département de Gynécologie-Obstétrique - Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques Baldauf, MD
Phone
3.33.88.12.74.59
Email
jean-jacques.baldauf@chru-strasbourg.fr
12. IPD Sharing Statement
Learn more about this trial
Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix.
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