Brief Title
Management of Cervical Intraepithelial Neoplasia Grade 2
Official Title
Management of Cervical Intraepithelial Neoplasia Grade 2
Brief Summary
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.
Detailed Description
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
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%
Condition
Cervical Intraepithelial Neoplasia
Intervention
Excision of the lesion
Study Arms / Comparison Groups
excision of the lesion
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
90
Start Date
March 2003
Completion Date
July 2007
Primary Completion Date
July 2006
Eligibility Criteria
Inclusion Criteria: - Histological CIN2 diagnosis Exclusion Criteria: - Previous CIN treatment
Gender
Female
Ages
18 Years - 61 Years
Accepts Healthy Volunteers
No
Contacts
Sylvia F Brenna, MD, PhD, ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT00733109
Organization ID
CIN 2
Study Sponsor
Universidade Cidade de Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Study Sponsor
Sylvia F Brenna, MD, PhD, Principal Investigator, Universidade Cidade de Sao Paulo
Verification Date
August 2008