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

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).

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.