Immediate Treatment vs Colposcopic Follow-up for Biopsy-Proven CIN 1
Cervical Intraepithelial Neoplasia
About this trial
This is an interventional treatment trial for Cervical Intraepithelial Neoplasia focused on measuring CIN 1, cervical intraepithelial neoplasia, cervix, cancer, loop electrosurgical excision procedure, LEEP, expectant management, human papilloma virus, HPV, colposcopy
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; 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.
Sites / Locations
- Universidade Estadual de Campinas
- Instituto Fernandes Figueira - Oswaldo Cruz Foundation
- B.C. Cancer Agency
- Nova Scotia Cancer Centre
- Brantford General Hospital
- Hamilton Health Sciences - Henderson Site
- London Health Sciences Centre
- St. Michael's Hospital
- University of Saskatchewan
- Hôpital du Saint-Sacrement
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
1
2
Immediate Treatment - LEEP - Loop electrosurgical excision procedure
Colposcopic Follow-up