NCT00733109

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
Last Updated

January 11, 2010

Status Verified

August 1, 2008

Enrollment Period

3.3 years

First QC Date

August 7, 2008

Last Update Submit

January 8, 2010

Conditions

Cervical Intraepithelial Neoplasia

Keywords

CIN2management

Outcome Measures

Primary Outcomes (1)

  • 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%

    12 months

Study Arms (2)

excision of the lesion

ACTIVE COMPARATOR
Procedure: Excision of the lesion

espontaneous regression

NO INTERVENTION
Other: Follow-up for spontaneous regression of the lesion

Interventions

Excision of the lesionPROCEDURE

Surgery with Large Loop Excision of Transformation Zone (LLETZ)

Also known as: LEETZ
excision of the lesion
Follow-up for spontaneous regression of the lesionOTHER

Follow-up at last 12 months

Also known as: conservative managment
espontaneous regression

Eligibility Criteria

Age18 Years - 61 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Histological CIN2 diagnosis

You may not qualify if:

  • Previous CIN treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leonor Mendes de Barros Maternity Hospital

São Paulo, São Paulo, 03015000, Brazil

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Sylvia F Brenna, MD, PhD

    Universidade Cidade de Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Ana C Guedes, MD, PhD

    Universidade Cidade de Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Kari J Sirjanen, MD, PhD

    University of Turku

    STUDY CHAIR

  • Luis C Zeferino, MD, PhD

    University of Campinas, Brazil

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 7, 2008

First Posted

August 12, 2008

Study Start

March 1, 2003

Primary Completion

July 1, 2006

Study Completion

July 1, 2007

Last Updated

January 11, 2010

Record last verified: 2008-08

Locations

BR(1)