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

• ClinicalTrials.gov Identifier: NCT00156026
• Recruitment Status: Completed
• First Posted: September 12, 2005
• Last Update Posted: January 29, 2009
• Sponsor: Ontario Clinical Oncology Group (OCOG)
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Information provided by: Ontario Clinical Oncology Group (OCOG)

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.

Condition or disease	Intervention/treatment	Phase
Cervical Intraepithelial Neoplasia	Procedure: loop electrosurgical excision procedure (LEEP)	Phase 3

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).

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. progression to more advanced disease [ Time Frame: 18 months ]

Secondary Outcome Measures :

1. persistent CIN 1 after 18 months [ Time Frame: 18 months ]
2. bleeding. [ Time Frame: 18 months ]
3. predict disease persistence or progression [ Time Frame: 18 months ]

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes 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

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

• 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
• Last Update Posted: January 29, 2009
• Last Verified: January 2009

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:

Neoplasms; Cervical Intraepithelial Neoplasia; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type