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

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.