Spots Global Cancer Trial Database for Immediate Treatment vs Colposcopic Follow-up for Biopsy-Proven CIN 1
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Trial Identification
Brief Title: Immediate Treatment vs Colposcopic Follow-up for Biopsy-Proven CIN 1
Official Title: Randomized Trial of Immediate Treatment vs. Colposcopic Follow-up for Biopsy-Proven CIN 1
Study ID: NCT00156026
Conditions
Interventions
Study Description
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 treatment using LEEP. The primary outcome is progression to more advanced disease (i.e., CIN 2, CIN 3 or cancer).
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Universidade Estadual de Campinas, Campinas, , Brazil
Instituto Fernandes Figueira - Oswaldo Cruz Foundation, Rio de Janeiro, , Brazil
B.C. Cancer Agency, Vancouver, British Columbia, Canada
Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
Brantford General Hospital, Brantford, Ontario, Canada
Hamilton Health Sciences - Henderson Site, Hamilton, Ontario, Canada
London Health Sciences Centre, London, Ontario, Canada
St. Michael's Hospital, Toronto, Ontario, Canada
University of Saskatchewan, Saskatoon, Saskatchewan, Canada
Hôpital du Saint-Sacrement, Quebec, , Canada
Contact Details
Name: Laurie Elit, MD
Affiliation: Juravinski Cancer Centre
Role: STUDY_CHAIR
Name: Mark Levine, MD
Affiliation: Ontario Clinical Oncology Group (OCOG)
Role: PRINCIPAL_INVESTIGATOR
Name: Jim Julian, MMath
Affiliation: McMaster University, Dept of Clinical Epidemiology & Biostatistics
Role: PRINCIPAL_INVESTIGATOR
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