Preinvasive Cervical Disease Cancer Cervical
Conditions
Interventions
1. Colposcopic Follow up for 18 months
2. Immediate LEEP treatment
Trial details received: 12 Sept 2005
Sponsors
McMaster University (Canada) - Faculty of Health Sciences
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Documented CIN 1 by histologic assessment as the highest grade lesion present 2. Lesion confined to the cervix and completely visualized 3. Be 16 years or older, female
Exclusion criteria
Exclusion criteria: Among patients satisfying the inclusion criteria the following will be excluding characteristics: 1. Index Pap smear showing CIN 2, 3 or cancer: 1.1. Index Pap smear shows atypical glandular cells of unknown significance, glandular dysplasia or malignancy requiring immediate investigation 1.2. Patients with previously identified CIN 1 by biopsy who are already in a surveillance program 2. 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 3. Pregnancy 4. Prior therapy for dysplasia including medical (5FU), surgical (Laser, LEEP) or cryotherapy 5. Prior gynecologic cancer 6. Prior pelvic radiation therapy 7. Inability to attend outpatient followup visits because of geographic inaccessibility 8. Other malignancies except non-melanoma skin cancer 9. Immunosuppression due to diseases such as Acquired Immune Deficiency Syndrome (AIDS), organ transplantation, or on immunosuppressive medications such as prednisone, imuran or chemotherapy for diseases like systemic lupus 10. Cognitively impaired or otherwise unable to obtain written informed consent 11. Extension of the CIN 1 lesion to vagina or a separate vaginal lesion showing dysplasia 12. Colposcopically visible condyloma outside of the transformation zone 13. Known allergy to local analgesics 14. Clinically evident vaginitis must be treated and resolved prior to entry on the trial 15. Inability to read and respond in English 16. Failure to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression to CIN 2 or worse within 18 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Persistent CIN 1 at 18 months 2. Adverse events 3. Assess the following prognostic factors: persistent versus incident disease, lesion size, patient?s age, smoking, Human Papillomavirus (HPV) type and load | — |
Countries
Canada
Outcome results
None listed