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Management of Cervical Intraepithelial Neoplasia Grade 2

Management of Cervical Intraepithelial Neoplasia Grade 2

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00733109
Acronym
CIN2
Enrollment
90
Registered
2008-08-12
Start date
2003-03-31
Completion date
2007-07-31
Last updated
2010-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Intraepithelial Neoplasia

Keywords

CIN2, management

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.

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.

Interventions

PROCEDUREExcision of the lesion

Surgery with Large Loop Excision of Transformation Zone (LLETZ)

OTHERFollow-up for spontaneous regression of the lesion

Follow-up at last 12 months

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Universidade Cidade de Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 61 Years
Healthy volunteers
No

Inclusion criteria

* Histological CIN2 diagnosis

Exclusion criteria

* Previous CIN treatment

Design outcomes

Primary

MeasureTime frame
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026