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

Overview

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.

Full Title of Study: “Randomized Trial of Immediate Treatment vs. Colposcopic Follow-up for Biopsy-Proven CIN 1″

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2007

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).

Interventions

  • Procedure: loop electrosurgical excision procedure (LEEP)
    • 1. loop electrosurgical excision procedure

Arms, Groups and Cohorts

  • Experimental: 1
    • Immediate Treatment – LEEP – Loop electrosurgical excision procedure
  • No Intervention: 2
    • Colposcopic Follow-up

Clinical Trial Outcome Measures

Primary Measures

  • progression to more advanced disease
    • Time Frame: 18 months

Secondary Measures

  • persistent CIN 1 after 18 months
    • Time Frame: 18 months
  • bleeding.
    • Time Frame: 18 months
  • predict disease persistence or progression
    • Time Frame: 18 months

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ontario Clinical Oncology Group (OCOG)
  • Collaborator
    • Canadian Institutes of Health Research (CIHR)
  • Provider of Information About this Clinical Study
    • Dr. Mark Levine, Ontario Clinical Oncology Group
  • Overall Official(s)
    • Laurie Elit, MD, Study Chair, Juravinski Cancer Centre
    • Mark Levine, MD, Principal Investigator, Ontario Clinical Oncology Group (OCOG)
    • Jim Julian, MMath, Principal Investigator, McMaster University, Dept of Clinical Epidemiology & Biostatistics

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