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

Ontario Clinical Oncology Group (OCOG)10 sites in 2 countries415 target enrollmentNovember 2000

ConditionsCervical Intraepithelial Neoplasia

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Cervical Intraepithelial Neoplasia
Sponsor: Ontario Clinical Oncology Group (OCOG)
Enrollment: 415
Locations: 10
Primary Endpoint: progression to more advanced disease
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

November 2000

End Date

September 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Ontario Clinical Oncology Group (OCOG)

Eligibility Criteria

Inclusion Criteria

•Eligible patients will:
•have documented CIN 1 by histologic assessment as the highest grade lesion present,
•have the lesion confined to the cervix and completely visualized,
•be 16 years or older.

Exclusion Criteria

•any one of the following will be an excluding characteristic:
•index Pap smear showing CIN 2, CIN 3 or cancer;
•index Pap smear shows atypical glandular cells of unknown significance, glandular dysplasia, or malignancy requiring immediate investigation;
•patients with previously identified CIN 1 by biopsy who are already in a colposcopic surveillance program;
•unsatisfactory colposcopic exam defined as inability to see the extent of the lesion in the endocervical canal or absence of a lesion on the ectocervix but endocervical curettage shows CIN 1;
•pregnancy;
•prior therapy for dysplasia including medical (5FU), surgical (Laser, LEEP) or cryotherapy;
•prior gynecologic cancer;
•prior pelvic radiation therapy;
•inability to attend outpatient follow-up visits because of geographic inaccessibility;