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

Primary Purpose

Cervical Intraepithelial Neoplasia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
loop electrosurgical excision procedure (LEEP)
Sponsored by
Ontario Clinical Oncology Group (OCOG)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia focused on measuring CIN 1, cervical intraepithelial neoplasia, cervix, cancer, loop electrosurgical excision procedure, LEEP, expectant management, human papilloma virus, HPV, colposcopy

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Estadual de Campinas
  • Instituto Fernandes Figueira - Oswaldo Cruz Foundation
  • B.C. Cancer Agency
  • Nova Scotia Cancer Centre
  • Brantford General Hospital
  • Hamilton Health Sciences - Henderson Site
  • London Health Sciences Centre
  • St. Michael's Hospital
  • University of Saskatchewan
  • Hôpital du Saint-Sacrement

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Immediate Treatment - LEEP - Loop electrosurgical excision procedure

Colposcopic Follow-up

Outcomes

Primary Outcome Measures

progression to more advanced disease

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2005
Last Updated
January 28, 2009
Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00156026
Brief Title
Immediate Treatment vs Colposcopic Follow-up for Biopsy-Proven CIN 1
Official Title
Randomized Trial of Immediate Treatment vs. Colposcopic Follow-up for Biopsy-Proven CIN 1
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia
Keywords
CIN 1, cervical intraepithelial neoplasia, cervix, cancer, loop electrosurgical excision procedure, LEEP, expectant management, human papilloma virus, HPV, colposcopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
415 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Immediate Treatment - LEEP - Loop electrosurgical excision procedure
Arm Title
2
Arm Type
No Intervention
Arm Description
Colposcopic Follow-up
Intervention Type
Procedure
Intervention Name(s)
loop electrosurgical excision procedure (LEEP)
Intervention Description
1. loop electrosurgical excision procedure
Primary Outcome Measure Information:
Title
progression to more advanced disease
Time Frame
18 months
Secondary Outcome Measure Information:
Title
persistent CIN 1 after 18 months
Time Frame
18 months
Title
bleeding.
Time Frame
18 months
Title
predict disease persistence or progression
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie Elit, MD
Organizational Affiliation
Juravinski Cancer Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mark Levine, MD
Organizational Affiliation
Ontario Clinical Oncology Group (OCOG)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jim Julian, MMath
Organizational Affiliation
McMaster University, Dept of Clinical Epidemiology & Biostatistics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Estadual de Campinas
City
Campinas
ZIP/Postal Code
CEP 13083-970
Country
Brazil
Facility Name
Instituto Fernandes Figueira - Oswaldo Cruz Foundation
City
Rio de Janeiro
ZIP/Postal Code
CEP 22250-020
Country
Brazil
Facility Name
B.C. Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Nova Scotia Cancer Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Brantford General Hospital
City
Brantford
State/Province
Ontario
ZIP/Postal Code
N3T 3J2
Country
Canada
Facility Name
Hamilton Health Sciences - Henderson Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8P 3A9
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 3H3
Country
Canada
Facility Name
Hôpital du Saint-Sacrement
City
Quebec
ZIP/Postal Code
G1S 2L6
Country
Canada

12. IPD Sharing Statement

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

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