CClinicalTrials.gg
CompletedNCT00156026Updated Jan 29, 2009

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

A Phase 3 interventional study of loop electrosurgical excision procedure (LEEP) in Cervical Intraepithelial Neoplasia, sponsored by Ontario Clinical Oncology Group (OCOG). Completed at 10 sites in 2 countries. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2009-01-29.

Sponsored by Ontario Clinical Oncology Group (OCOG) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
415
Allocation
Randomized
Ages
16 Years and older
Sex
Female
01

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.

Read the 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).

02

Conditions studied

  • Cervical Intraepithelial Neoplasia

Keywords

  • CIN 1
  • cervical intraepithelial neoplasia
  • cervix
  • cancer
  • loop electrosurgical excision procedure
  • LEEP
  • expectant management
  • human papilloma virus
  • HPV
  • colposcopy
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 415 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Ontario Clinical Oncology Group (OCOG) is the lead sponsor of 56 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
415 participants (actual)

Study arms

  • Experimental
    1

    Immediate Treatment - LEEP - Loop electrosurgical excision procedure

    Procedure: loop electrosurgical excision procedure (LEEP)

  • No intervention
    2

    Colposcopic Follow-up

Interventions

  • Procedureloop electrosurgical excision procedure (LEEP)

    1. loop electrosurgical excision procedure

06

What researchers measure

Primary outcomes

  1. progression to more advanced disease

    Time frame: 18 months

Secondary outcomes

  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

07

Study locations

10 sites
  • Universidade Estadual de Campinas
    Campinas, CEP 13083-970, Brazil
  • Instituto Fernandes Figueira - Oswaldo Cruz Foundation
    Rio de Janeiro, CEP 22250-020, Brazil
  • B.C. Cancer Agency
    Vancouver, British Columbia V5Z 4E6, Canada
  • Nova Scotia Cancer Centre
    Halifax, Nova Scotia B3H 1V7, Canada
  • Brantford General Hospital
    Brantford, Ontario N3T 3J2, Canada
  • Hamilton Health Sciences - Henderson Site
    Hamilton, Ontario L8P 3A9, Canada
  • London Health Sciences Centre
    London, Ontario N6A 4G5, Canada
  • St. Michael's Hospital
    Toronto, Ontario M5B 1W8, Canada
  • University of Saskatchewan
    Saskatoon, Saskatchewan S7K 3H3, Canada
  • Hôpital du Saint-Sacrement
    Quebec, G1S 2L6, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00156026
Lead sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Canadian Institutes of Health Research (CIHR)
First posted
Sep 12, 2005
Start date
Nov 2000
Primary completion
Sep 2007
Completion
Sep 2007
Last update
Jan 29, 2009

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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