Management of Cervical Intraepithelial Neoplasia Grade 2 (CIN2)

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Universidade Cidade de Sao Paulo
ClinicalTrials.gov Identifier:
NCT00733109
First received: August 7, 2008
Last updated: January 8, 2010
Last verified: August 2008

August 7, 2008
January 8, 2010
March 2003
July 2006   (final data collection date for primary outcome measure)
43 women in the follow-up group, 44.1% experienced spontaneous regression, 20.9% had partial regression, 23.2% progressed to CIN3, and 11.6% showed persistence. 44 women whose lesion was excised, the regression rate was 90.9% [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00733109 on ClinicalTrials.gov Archive Site
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Management of Cervical Intraepithelial Neoplasia Grade 2
Management of Cervical Intraepithelial Neoplasia Grade 2

The aim of this study was to compare two management options for CIN 2. This randomized clinical trial performed between 2003 and 2006. A series of 90 Brazilian women diagnosed as CIN2 were randomized into two groups: 1) 45 whose lesion was excised and,2) 45 women subjected to follow-up at 3-month intervals for 12 months.

Pap smear and colposcopy were performed at every follow-up visit and all lesions were completely visible at colposcopy.

The researchers purpose was to make some comments about the over treatment and the misclassification of CIN 2.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Cervical Intraepithelial Neoplasia
  • Procedure: Excision of the lesion
    Surgery with Large Loop Excision of Transformation Zone (LLETZ)
    Other Name: LEETZ
  • Other: Follow-up for spontaneous regression of the lesion
    Follow-up at last 12 months
    Other Name: conservative managment
  • Active Comparator: excision of the lesion
    Intervention: Procedure: Excision of the lesion
  • No Intervention: espontaneous regression
    Intervention: Other: Follow-up for spontaneous regression of the lesion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
July 2007
July 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histological CIN2 diagnosis

Exclusion Criteria:

  • Previous CIN treatment
Female
18 Years to 61 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00733109
CIN 2
Yes
Jose Lucio Martins Machado, UNICID- School of Medical Sciense
Universidade Cidade de Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Sylvia F Brenna, MD, PhD Universidade Cidade de Sao Paulo
Principal Investigator: Ana C Guedes, MD, PhD Universidade Cidade de Sao Paulo
Study Chair: Kari J Sirjanen, MD, PhD University of Turku
Study Director: Luis C Zeferino, MD, PhD University of Campinas, Brazil
Universidade Cidade de Sao Paulo
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP