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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
Open (Enrolling)
Female
Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)

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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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