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Immediate Treatment vs Colposcopic Follow-up for Biopsy-Proven CIN 1

2014-07-23 21:48:47 | BioPortfolio

Summary

This study looks at immediate treatment of a cervix with CIN 1 versus regular six-month follow-up with colposcopy and treatment if CIN 1 progresses.

Description

In women who present with biopsy-proven CIN 1, to compare the management approach of regular colposcopic follow-up and only treating progressive disease using the LEEP, with an approach of immediate treatment using LEEP. The primary outcome is progression to more advanced disease (i.e., CIN 2, CIN 3 or cancer).

Study Design

Allocation: Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cervical Intraepithelial Neoplasia

Intervention

loop electrosurgical excision procedure (LEEP)

Location

Universidade Estadual de Campinas
Campinas
British Columbia
Brazil
CEP 13083-970

Status

Completed

Source

Ontario Clinical Oncology Group (OCOG)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:48:47-0400

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Medical and Biotech [MESH] Definitions

A malignancy arising in uterine cervical epithelium and confined thereto, representing a continuum of histological changes ranging from well-differentiated CIN 1 (formerly, mild dysplasia) to severe dysplasia/carcinoma in situ, CIN 3. The lesion arises at the squamocolumnar cell junction at the transformation zone of the endocervical canal, with a variable tendency to develop invasive epidermoid carcinoma, a tendency that is enhanced by concomitant human papillomaviral infection. (Segen, Dictionary of Modern Medicine, 1992)

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