Management of Cervical Intraepithelial Neoplasia Grade 2

Cervical Intraepithelial Neoplasia Clinical Trial

— CIN2  

Official title:

Management of Cervical Intraepithelial Neoplasia Grade 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733109
• Other study ID #: CIN 2
• Status: Completed
• Phase: Phase 4
• First received: August 7, 2008
• Last updated: January 8, 2010
• Start date: March 2003
• Est. completion date: July 2007

Study information

• Verified date: August 2008
• Source: Universidade Cidade de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2007
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 61 Years

Eligibility

Inclusion Criteria:

• Histological CIN2 diagnosis

Exclusion Criteria:

• Previous CIN treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Neoplasms
• Uterine Cervical Dysplasia

Intervention

Procedure:
• Excision of the lesion
Surgery with Large Loop Excision of Transformation Zone (LLETZ)

Other:
• Follow-up for spontaneous regression of the lesion
Follow-up at last 12 months

Locations

Country	Name	City	State
Brazil	Leonor Mendes de Barros Maternity Hospital	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes