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

Phase 3

Completed

• Conditions: Cervical Intraepithelial Neoplasia
• Interventions: Procedure: loop electrosurgical excision procedure (LEEP)

• Registration Number: NCT00156026
• Lead Sponsor: Ontario Clinical Oncology Group (OCOG)

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.

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 Timeline

• Study Start: 2000-11
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-28
• Last Update Posted: 2009-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 415

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	loop electrosurgical excision procedure (LEEP)	Immediate Treatment - LEEP - Loop electrosurgical excision procedure

Primary Outcome Measures

Name	Time	Method
progression to more advanced disease	18 months

Secondary Outcome Measures

Name	Time	Method
persistent CIN 1 after 18 months	18 months
bleeding.	18 months
predict disease persistence or progression	18 months

Trial Locations

Locations (10)

Brantford General Hospital; 🇨🇦 Brantford, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Hôpital du Saint-Sacrement; 🇨🇦 Quebec, Canada

Hamilton Health Sciences - Henderson Site; 🇨🇦 Hamilton, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Instituto Fernandes Figueira - Oswaldo Cruz Foundation; 🇧🇷 Rio de Janeiro, Brazil

Universidade Estadual de Campinas; 🇧🇷 Campinas, Brazil

Nova Scotia Cancer Centre; 🇨🇦 Halifax, Nova Scotia, Canada

B.C. Cancer Agency; 🇨🇦 Vancouver, British Columbia, Canada

University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada