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
  Purpose

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.


Condition Intervention Phase
Cervical Intraepithelial Neoplasia
Procedure: Excision of the lesion
Other: Follow-up for spontaneous regression of the lesion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Management of Cervical Intraepithelial Neoplasia Grade 2

Resource links provided by NLM:


Further study details as provided by Universidade Cidade de Sao Paulo:

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% [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: March 2003
Study Completion Date: July 2007
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: excision of the lesion Procedure: Excision of the lesion
Surgery with Large Loop Excision of Transformation Zone (LLETZ)
Other Name: LEETZ
No Intervention: espontaneous regression Other: Follow-up for spontaneous regression of the lesion
Follow-up at last 12 months
Other Name: conservative managment

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.

  Eligibility

Ages Eligible for Study:   18 Years to 61 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological CIN2 diagnosis

Exclusion Criteria:

  • Previous CIN treatment
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00733109

Locations
Brazil
Leonor Mendes de Barros Maternity Hospital
São Paulo, Brazil, 03015000
Sponsors and Collaborators
Universidade Cidade de Sao Paulo
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
  More Information

No publications provided

Responsible Party: Jose Lucio Martins Machado, UNICID- School of Medical Sciense
ClinicalTrials.gov Identifier: NCT00733109     History of Changes
Other Study ID Numbers: CIN 2
Study First Received: August 7, 2008
Last Updated: January 8, 2010
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Cidade de Sao Paulo:
CIN2
management

Additional relevant MeSH terms:
Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Uterine Cervical Dysplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 18, 2014