Management of Cervical Intraepithelial Neoplasia Grade 2

NCT ID: NCT00733109

Last Updated: 2010-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2007-07-31

Brief Summary

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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

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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.

Conditions

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Cervical Intraepithelial Neoplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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excision of the lesion

Group Type ACTIVE_COMPARATOR

Excision of the lesion

Intervention Type PROCEDURE

Surgery with Large Loop Excision of Transformation Zone (LLETZ)

espontaneous regression

Group Type NO_INTERVENTION

Follow-up for spontaneous regression of the lesion

Intervention Type OTHER

Follow-up at last 12 months

Interventions

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Excision of the lesion

Surgery with Large Loop Excision of Transformation Zone (LLETZ)

Intervention Type PROCEDURE

Follow-up for spontaneous regression of the lesion

Follow-up at last 12 months

Intervention Type OTHER

Other Intervention Names

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LEETZ conservative managment

Eligibility Criteria

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Inclusion Criteria

* Histological CIN2 diagnosis

Exclusion Criteria

* Previous CIN treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

61 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Universidade Cidade de Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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UNICID- School of Medical Sciense

Principal Investigators

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Sylvia F Brenna, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Cidade de Sao Paulo

Ana C Guedes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Cidade de Sao Paulo

Kari J Sirjanen, MD, PhD

Role: STUDY_CHAIR

University of Turku

Luis C Zeferino, MD, PhD

Role: STUDY_DIRECTOR

University of Campinas, Brazil

Locations

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Leonor Mendes de Barros Maternity Hospital

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CIN 2

Identifier Type: -

Identifier Source: org_study_id

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