Immediate Treatment vs Colposcopic Follow-up for Biopsy-Proven CIN 1
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ClinicalTrials.gov Identifier: NCT00156026 |
Recruitment Status :
Completed
First Posted : September 12, 2005
Last Update Posted : January 29, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Intraepithelial Neoplasia | Procedure: loop electrosurgical excision procedure (LEEP) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 415 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Trial of Immediate Treatment vs. Colposcopic Follow-up for Biopsy-Proven CIN 1 |
Study Start Date : | November 2000 |
Actual Primary Completion Date : | September 2007 |
Actual Study Completion Date : | September 2007 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
Immediate Treatment - LEEP - Loop electrosurgical excision procedure
|
Procedure: loop electrosurgical excision procedure (LEEP)
1. loop electrosurgical excision procedure |
No Intervention: 2
Colposcopic Follow-up
|
- progression to more advanced disease [ Time Frame: 18 months ]
- persistent CIN 1 after 18 months [ Time Frame: 18 months ]
- bleeding. [ Time Frame: 18 months ]
- predict disease persistence or progression [ Time Frame: 18 months ]

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
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 Criteria:
-
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156026
Brazil | |
Universidade Estadual de Campinas | |
Campinas, Brazil, CEP 13083-970 | |
Instituto Fernandes Figueira - Oswaldo Cruz Foundation | |
Rio de Janeiro, Brazil, CEP 22250-020 | |
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 | |
Brantford General Hospital | |
Brantford, Ontario, Canada, N3T 3J2 | |
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 | |
Canada, Saskatchewan | |
University of Saskatchewan | |
Saskatoon, Saskatchewan, Canada, S7K 3H3 | |
Canada | |
Hôpital du Saint-Sacrement | |
Quebec, Canada, G1S 2L6 |
Study Chair: | Laurie Elit, MD | Juravinski Cancer Centre | |
Principal Investigator: | Mark Levine, MD | Ontario Clinical Oncology Group (OCOG) | |
Principal Investigator: | Jim Julian, MMath | McMaster University, Dept of Clinical Epidemiology & Biostatistics |
Responsible Party: | Dr. Mark Levine, Ontario Clinical Oncology Group |
ClinicalTrials.gov Identifier: | NCT00156026 |
Other Study ID Numbers: |
OCOG-2000-CIN1 |
First Posted: | September 12, 2005 Key Record Dates |
Last Update Posted: | January 29, 2009 |
Last Verified: | January 2009 |
CIN 1 cervical intraepithelial neoplasia cervix cancer loop electrosurgical excision procedure |
LEEP expectant management human papilloma virus HPV colposcopy |
Neoplasms Cervical Intraepithelial Neoplasia Carcinoma in Situ |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |