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Management of Cervical Intraepithelial Neoplasia Grade 2 (CIN2)

Primary Purpose

Cervical Intraepithelial Neoplasia

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Excision of the lesion
Follow-up for spontaneous regression of the lesion
Sponsored by
Universidade Cidade de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia focused on measuring CIN2, management

Eligibility Criteria

18 Years - 61 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histological CIN2 diagnosis

Exclusion Criteria:

  • Previous CIN treatment

Sites / Locations

  • Leonor Mendes de Barros Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

excision of the lesion

espontaneous regression

Arm Description

Outcomes

Primary Outcome Measures

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%

Secondary Outcome Measures

Full Information

First Posted
August 7, 2008
Last Updated
January 8, 2010
Sponsor
Universidade Cidade de Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00733109
Brief Title
Management of Cervical Intraepithelial Neoplasia Grade 2
Acronym
CIN2
Official Title
Management of Cervical Intraepithelial Neoplasia Grade 2
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universidade Cidade de Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia
Keywords
CIN2, management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
excision of the lesion
Arm Type
Active Comparator
Arm Title
espontaneous regression
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Excision of the lesion
Other Intervention Name(s)
LEETZ
Intervention Description
Surgery with Large Loop Excision of Transformation Zone (LLETZ)
Intervention Type
Other
Intervention Name(s)
Follow-up for spontaneous regression of the lesion
Other Intervention Name(s)
conservative managment
Intervention Description
Follow-up at last 12 months
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological CIN2 diagnosis Exclusion Criteria: Previous CIN treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvia F Brenna, MD, PhD
Organizational Affiliation
Universidade Cidade de Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana C Guedes, MD, PhD
Organizational Affiliation
Universidade Cidade de Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kari J Sirjanen, MD, PhD
Organizational Affiliation
University of Turku
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Luis C Zeferino, MD, PhD
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Study Director
Facility Information:
Facility Name
Leonor Mendes de Barros Maternity Hospital
City
São Paulo
ZIP/Postal Code
03015000
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Management of Cervical Intraepithelial Neoplasia Grade 2

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