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

NCT00343213 | Unknown

• 1 other identifier: 3454
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)

Keywords

Prognostic value of p16INK4a; CIN 1; LSIL; HPV

Outcome Measures

Primary Outcomes (1)

• p16INK4a staining pattern and HPV status of the initial biopsy

Secondary Outcomes (1)

• p16INK4a staining pattern and histologic diagnosis of follow-up biopsies correlated with colposcopic findings.

Interventions

colposcopy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Responsible women \> 18 years with histologically proven CIN 1

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (3)

Service de Gynécologie-Obstétrique - Centre Hospitalier Général

Haguenau, France

RECRUITING

Service de gynécologie-obtétrique - Centre Hospitalier Général

Saverne, France

RECRUITING

Département de Gynécologie-Obstétrique - Hôpital de Hautepierre

Strasbourg, 67098, France

RECRUITING

MeSH Terms

Interventions

Colposcopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Jean-Jacques Baldauf, MD

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

  STUDY DIRECTOR

Central Study Contacts

Jean-Jacques Baldauf, MD

CONTACT

3.33.88.12.74.59; jean-jacques.baldauf@chru-strasbourg.fr

Gerlinde Averous

CONTACT

3.33.88.12.70.52; gerlinde.averous@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 21, 2006
• First Posted: June 22, 2006
• Study Start: June 1, 2006
• Last Updated: August 30, 2011

Record last verified: 2011-08

Locations

FR (3)