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.
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)
Female
Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)
Trial Information
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.
Inclusion Criteria
Responsible women > 18 years with histologically proven CIN 1
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Outcome Measure:
p16INK4a staining pattern and HPV status of the initial biopsy
Principal Investigator
Jean-Jacques Baldauf, MD
Investigator Role:
Study Director
Investigator Affiliation:
Département de Gynécologie-Obstétrique - Hôpital de Hautepierre - Strasbourg - France
Authority:
France: Ministry of Health
Study ID:
3454
NCT ID:
NCT00343213
Start Date:
June 2006
Completion Date:
Related Keywords:
- Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)
- Prognostic value of p16INK4a
- CIN 1
- LSIL
- HPV
- Neoplasms
- Cervical Intraepithelial Neoplasia
- Uterine Cervical Dysplasia
- Carcinoma in Situ
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