Status:
COMPLETED
Immediate Treatment vs Colposcopic Follow-up for Biopsy-Proven CIN 1
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
16+ years
Phase:
PHASE3
Brief Summary
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.
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
415 Patients enrolled
Trial Details
Trial ID
NCT00156026
Start Date
November 1 2000
End Date
September 1 2007
Last Update
January 29 2009
Active Locations (10)
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1
Universidade Estadual de Campinas
Campinas, Brazil, CEP 13083-970
2
Instituto Fernandes Figueira - Oswaldo Cruz Foundation
Rio de Janeiro, Brazil, CEP 22250-020
3
B.C. Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
4
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7