NCT00156026

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

Randomized Trial of Immediate Treatment vs. Colposcopic Follow-up for Biopsy-Proven CIN 1

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 415 (actual)
• Sponsor: Ontario Clinical Oncology Group (OCOG) · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
PROCEDURE	loop electrosurgical excision procedure (LEEP)	1\. loop electrosurgical excision procedure

Timeline

• Start date: 2000-11-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2005-09-12
• Last updated: 2009-01-29

Locations

10 sites across 2 countries: Brazil, Canada