NCT00156026

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
415

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2000

Longer than P75 for phase_3

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

Enrollment Period

6.8 years

First QC Date

September 8, 2005

Last Update Submit

January 28, 2009

Conditions

Cervical Intraepithelial Neoplasia

Keywords

CIN 1cervical intraepithelial neoplasiacervixcancerloop electrosurgical excision procedureLEEPexpectant managementhuman papilloma virusHPVcolposcopy

Outcome Measures

Primary Outcomes (1)

  • progression to more advanced disease

    18 months

Secondary Outcomes (3)

  • persistent CIN 1 after 18 months

    18 months

  • bleeding.

    18 months

  • predict disease persistence or progression

    18 months

Study Arms (2)

1

EXPERIMENTAL

Immediate Treatment - LEEP - Loop electrosurgical excision procedure

Procedure: loop electrosurgical excision procedure (LEEP)

2

NO INTERVENTION

Colposcopic Follow-up

Interventions

loop electrosurgical excision procedure (LEEP)PROCEDURE

1\. loop electrosurgical excision procedure

1

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Universidade Estadual de Campinas

Campinas, CEP 13083-970, Brazil

Location

Instituto Fernandes Figueira - Oswaldo Cruz Foundation

Rio de Janeiro, CEP 22250-020, Brazil

Location

B.C. Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Brantford General Hospital

Brantford, Ontario, N3T 3J2, Canada

Location

Hamilton Health Sciences - Henderson Site

Hamilton, Ontario, L8P 3A9, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Hôpital du Saint-Sacrement

Québec, Quebec, G1S 2L6, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, S7K 3H3, Canada

Location

MeSH Terms

Conditions

Uterine Cervical DysplasiaNeoplasms

Condition Hierarchy (Ancestors)

Precancerous ConditionsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Laurie Elit, MD

    Juravinski Cancer Centre

    STUDY CHAIR

  • Mark Levine, MD

    Ontario Clinical Oncology Group (OCOG)

    PRINCIPAL INVESTIGATOR

  • Jim Julian, MMath

    McMaster University, Dept of Clinical Epidemiology & Biostatistics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

November 1, 2000

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

January 29, 2009

Record last verified: 2009-01

Locations

BR(2)CA(8)