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Sponsors and Collaborators: |
Ontario Clinical Oncology Group (OCOG) Canadian Institutes of Health Research (CIHR) |
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Information provided by: | Ontario Clinical Oncology Group (OCOG) |
ClinicalTrials.gov Identifier: | NCT00156026 |
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.
Condition | Intervention | Phase |
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Cervical Intraepithelial Neoplasia |
Procedure: loop electrosurgical excision procedure (LEEP) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Trial of Immediate Treatment vs. Colposcopic Follow-up for Biopsy-Proven CIN 1 |
Enrollment: | 415 |
Study Start Date: | November 2000 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Immediate Treatment - LEEP - Loop electrosurgical excision procedure
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Procedure: loop electrosurgical excision procedure (LEEP)
1. loop electrosurgical excision procedure
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2: No Intervention
Colposcopic Follow-up
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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).
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligible patients will:
Exclusion Criteria:
any one of the following will be an excluding characteristic:
Brazil | |
Universidade Estadual de Campinas | |
Campinas, Brazil, CEP 13083-970 | |
Instituto Fernandes Figueira - Oswaldo Cruz Foundation | |
Rio de Janeiro, Brazil, CEP 22250-020 | |
Canada | |
Hôpital du Saint-Sacrement | |
Quebec, Canada, G1S 2L6 | |
Canada, British Columbia | |
B.C. Cancer Agency | |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Canada, Nova Scotia | |
Nova Scotia Cancer Centre | |
Halifax, Nova Scotia, Canada, B3H 1V7 | |
Canada, Ontario | |
Hamilton Health Sciences - Henderson Site | |
Hamilton, Ontario, Canada, L8P 3A9 | |
London Health Sciences Centre | |
London, Ontario, Canada, N6A 4G5 | |
St. Michael's Hospital | |
Toronto, Ontario, Canada, M5B 1W8 | |
Brantford General Hospital | |
Brantford, Ontario, Canada, N3T 3J2 | |
Canada, Saskatchewan | |
University of Saskatchewan | |
Saskatoon, Saskatchewan, Canada, S7K 3H3 |
Study Chair: | Laurie Elit, MD | Juravinski Cancer Centre |
Principal Investigator: | Mark Levine, MD | Ontario Clinical Oncology Group |
Principal Investigator: | Jim Julian, MMath | McMaster University, Dept of Clinical Epidemiology & Biostatistics |
Responsible Party: | Ontario Clinical Oncology Group ( Dr. Mark Levine ) |
Study ID Numbers: | OCOG-2000-CIN1 |
Study First Received: | September 8, 2005 |
Last Updated: | January 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00156026 History of Changes |
Health Authority: | Canada: Health Canada; Brazil: National Committee of Ethics in Research |
CIN 1 cervical intraepithelial neoplasia cervix cancer loop electrosurgical excision procedure |
LEEP expectant management human papilloma virus HPV colposcopy |
Virus Diseases Carcinoma in Situ Papilloma |
Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |
Neoplasms Neoplasms by Histologic Type Carcinoma in Situ |
Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |