Immediate Treatment vs Colposcopic Follow-up for Biopsy-Proven CIN 1

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00156026
First received: September 8, 2005
Last updated: January 28, 2009
Last verified: January 2009
  Purpose

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
Cervical Intraepithelial Neoplasia
Procedure: loop electrosurgical excision procedure (LEEP)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of Immediate Treatment vs. Colposcopic Follow-up for Biopsy-Proven CIN 1

Resource links provided by NLM:


Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • progression to more advanced disease [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • persistent CIN 1 after 18 months [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • bleeding. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • predict disease persistence or progression [ Time Frame: 18 months ] [ Designated as safety issue: No ]

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
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

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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156026

Locations
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
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Canadian Institutes of Health Research (CIHR)
Investigators
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
  More Information

No publications provided

Responsible Party: Dr. Mark Levine, Ontario Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00156026     History of Changes
Other Study ID Numbers: OCOG-2000-CIN1
Study First Received: September 8, 2005
Last Updated: January 28, 2009
Health Authority: Canada: Health Canada
Brazil: National Committee of Ethics in Research

Keywords provided by Ontario Clinical Oncology Group (OCOG):
CIN 1
cervical intraepithelial neoplasia
cervix
cancer
loop electrosurgical excision procedure
LEEP
expectant management
human papilloma virus
HPV
colposcopy

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 23, 2014