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

Ontario Clinical Oncology Group (OCOG)

Status and phase

Completed

Phase 3

Conditions

Cervical Intraepithelial Neoplasia

Treatments

Procedure: loop electrosurgical excision procedure (LEEP)

Study type

Interventional

Funder types

Other

Identifiers

NCT00156026

OCOG-2000-CIN1

Details and patient eligibility

About

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.

Full 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).

Enrollment

415 patients

Sex

Female

Ages

16+ years old

Volunteers

No Healthy Volunteers

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;
- other malignancies except non-melanoma skin cancer;
- immunosuppression due to diseases such as AIDS, organ transplantation, or on immunosuppressive medications such as prednisone, imuran or chemotherapy for diseases like systemic lupus;
- cognitively impaired or otherwise unable to obtain written informed consent;
- extension of the CIN 1 lesion to vagina or a separate vaginal lesion showing dysplasia;
- colposcopically visible condyloma outside of the transformation zone;
- known allergy to local analgesics;
- clinically evident vaginitis must be treated and resolved prior to entry on the trial;
- inability to read and respond in English/French;
- failure to provide informed consent.