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

Randomized Trial of Immediate Treatment vs. Colposcopic Follow-up for Biopsy-Proven CIN 1

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.

Study Overview

• Status: Completed
• Conditions: Cervical Intraepithelial Neoplasia
• Intervention / Treatment: Procedure: loop electrosurgical excision procedure (LEEP)

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 Type: Interventional
• Enrollment (Actual): 415
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Campinas, Brazil, CEP 13083-970
    • Universidade Estadual de Campinas
  • Rio de Janeiro, Brazil, CEP 22250-020
    • Instituto Fernandes Figueira - Oswaldo Cruz Foundation
• Canada
  • Quebec, Canada, G1S 2L6
    • Hopital Du Saint-Sacrement
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • B.C. Cancer Agency
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Nova Scotia Cancer Centre
  • Ontario
    • Brantford, Ontario, Canada, N3T 3J2
      • Brantford General Hospital
    • Hamilton, Ontario, Canada, L8P 3A9
      • Hamilton Health Sciences - Henderson Site
    • London, Ontario, Canada, N6A 4G5
      • London Health Sciences Centre
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 3H3
      • University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
progression to more advanced disease	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
persistent CIN 1 after 18 months	18 months
bleeding.	18 months
predict disease persistence or progression	18 months

Collaborators and Investigators

• Sponsor: Ontario Clinical Oncology Group (OCOG)
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Study Chair: Laurie Elit, MD, Juravinski Cancer Centre; Principal Investigator: Jim Julian, MMath, McMaster University, Dept of Clinical Epidemiology & Biostatistics

Study record dates

Study Major Dates

• Study Start: November 1, 2000
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 8, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Estimate): January 29, 2009
• Last Update Submitted That Met QC Criteria: January 28, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: cancer; colposcopy; cervical intraepithelial neoplasia; HPV; expectant management; loop electrosurgical excision procedure; human papilloma virus; CIN 1; cervix; LEEP
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma in Situ; Neoplasms; Cervical Intraepithelial Neoplasia
• Other Study ID Numbers: OCOG-2000-CIN1