Management of Cervical Intraepithelial Neoplasia Grade 2 (CIN2)

January 8, 2010 updated by: Universidade Cidade de Sao Paulo
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 03015000
        • Leonor Mendes de Barros Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 61 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histological CIN2 diagnosis

Exclusion Criteria:

  • Previous CIN treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: excision of the lesion
Procedure: Excision of the lesion
Surgery with Large Loop Excision of Transformation Zone (LLETZ)
Other Names:
  • LEETZ
No Intervention: espontaneous regression
Other: Follow-up for spontaneous regression of the lesion
Follow-up at last 12 months
Other Names:
  • conservative managment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Cidade de Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

August 7, 2008

First Submitted That Met QC Criteria

August 11, 2008

First Posted (Estimate)

August 12, 2008

Study Record Updates

Last Update Posted (Estimate)

January 11, 2010

Last Update Submitted That Met QC Criteria

January 8, 2010

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIN 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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