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Trial Title:
Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix.
NCT ID:
NCT00343213
Condition:
Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)
Conditions: Official terms:
Uterine Cervical Dysplasia
Squamous Intraepithelial Lesions of the Cervix
Conditions: Keywords:
Prognostic value of p16INK4a
CIN 1
LSIL
HPV
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Prevention
Masking:
Double
Intervention:
Intervention type:
Procedure
Intervention name:
colposcopy
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.
Criteria for eligibility:
Criteria:
Responsible women > 18 years with histologically proven CIN 1
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Service de Gynécologie-Obstétrique - Centre Hospitalier Général
Address:
City:
Haguenau
Country:
France
Status:
Recruiting
Contact:
Last name:
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
Address:
City:
Saverne
Country:
France
Status:
Recruiting
Contact:
Last name:
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
Address:
City:
Strasbourg
Zip:
67098
Country:
France
Status:
Recruiting
Contact:
Last name:
Jean-Jacques Baldauf, MD
Phone:
3.33.88.12.74.59
Email:
jean-jacques.baldauf@chru-strasbourg.fr
Start date:
June 2006
Lead sponsor:
Agency:
University Hospital, Strasbourg, France
Agency class:
Other
Source:
University Hospital, Strasbourg, France
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00343213
