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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Immediate Treatment - LEEP - Loop electrosurgical excision procedure |
|
| 2 | No Intervention | Colposcopic Follow-up |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| loop electrosurgical excision procedure (LEEP) | Procedure | 1. loop electrosurgical excision procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression to more advanced disease | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| persistent CIN 1 after 18 months | 18 months | |
| bleeding. | 18 months | |
| predict disease persistence or progression |
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Inclusion Criteria:
Eligible patients will:
Exclusion Criteria:
any one of the following will be an excluding characteristic:
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| Name | Affiliation | Role |
|---|---|---|
| Laurie Elit, MD | Juravinski Cancer Centre | Study Chair |
| Mark Levine, MD | Ontario Clinical Oncology Group (OCOG) | Principal Investigator |
| Jim Julian, MMath | McMaster University, Dept of Clinical Epidemiology & Biostatistics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Estadual de Campinas | Campinas | CEP 13083-970 | Brazil | |||
| Instituto Fernandes Figueira - Oswaldo Cruz Foundation |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
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| 18 months |
| Rio de Janeiro |
| CEP 22250-020 |
| Brazil |
| B.C. Cancer Agency | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Nova Scotia Cancer Centre | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Brantford General Hospital | Brantford | Ontario | N3T 3J2 | Canada |
| Hamilton Health Sciences - Henderson Site | Hamilton | Ontario | L8P 3A9 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 4G5 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Hôpital du Saint-Sacrement | Québec | Quebec | G1S 2L6 | Canada |
| University of Saskatchewan | Saskatoon | Saskatchewan | S7K 3H3 | Canada |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |