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

Last updated: January 28, 2009
Sponsor: Ontario Clinical Oncology Group (OCOG)
Overall Status: Completed

Phase

3

Condition

Neoplasms

Precancerous Condition

Genitourinary Cancer

Treatment

N/A

Clinical Study ID

NCT00156026
OCOG-2000-CIN1
  • Ages > 16
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eligible patients will:

  • have documented CIN 1 by histologic assessment as the highest grade lesionpresent,

  • have the lesion confined to the cervix and completely visualized,

  • be 16 years or older.

Exclusion

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, glandulardysplasia, or malignancy requiring immediate investigation;

  • patients with previously identified CIN 1 by biopsy who are already in acolposcopic surveillance program;

  • unsatisfactory colposcopic exam defined as inability to see the extent of thelesion in the endocervical canal or absence of a lesion on the ectocervix butendocervical curettage shows CIN 1;

  • pregnancy;

  • prior therapy for dysplasia including medical (5FU), surgical (Laser, LEEP) orcryotherapy;

  • prior gynecologic cancer;

  • prior pelvic radiation therapy;

  • inability to attend outpatient follow-up visits because of geographicinaccessibility;

  • other malignancies except non-melanoma skin cancer;

  • immunosuppression due to diseases such as AIDS, organ transplantation, or onimmunosuppressive medications such as prednisone, imuran or chemotherapy fordiseases 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 showingdysplasia;

  • 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 thetrial;

  • inability to read and respond in English/French;

  • failure to provide informed consent.

Study Design

Total Participants: 415
Study Start date:
November 01, 2000
Estimated Completion Date:
September 30, 2007

Study 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).

Connect with a study center

  • Universidade Estadual de Campinas

    Campinas, CEP 13083-970
    Brazil

    Site Not Available

  • Instituto Fernandes Figueira - Oswaldo Cruz Foundation

    Rio de Janeiro, CEP 22250-020
    Brazil

    Site Not Available

  • B.C. Cancer Agency

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • Brantford General Hospital

    Brantford, Ontario N3T 3J2
    Canada

    Site Not Available

  • Hamilton Health Sciences - Henderson Site

    Hamilton, Ontario L8P 3A9
    Canada

    Site Not Available

  • London Health Sciences Centre

    London, Ontario N6A 4G5
    Canada

    Site Not Available

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Site Not Available

  • University of Saskatchewan

    Saskatoon, Saskatchewan S7K 3H3
    Canada

    Site Not Available

  • Hôpital du Saint-Sacrement

    Quebec, G1S 2L6
    Canada

    Site Not Available

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