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OpenTrials
Completed

NCT Number: NCT00733109

Management of Cervical Intraepithelial Neoplasia Grade 2

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.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

18 year–61 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Leonor Mendes de Barros Maternity Hospital

São Paulo, 03015000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological CIN2 diagnosis

Exclusion criteria

  • Previous CIN treatment

Treatment and study plan

Excision of the lesion

Procedure

Surgery with Large Loop Excision of Transformation Zone (LLETZ)

Other names: LEETZ

Follow-up for spontaneous regression of the lesion

Other

Follow-up at last 12 months

Other names: conservative managment

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%

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Universidade Cidade de Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Acronym: CIN2

Important dates

Study start
2003
Primary completion
2006
Study completion
2007
First posted
Aug 12, 2008
Registry last updated
Jan 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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