Contact information
Type
Scientific
Primary contact
Dr Lorraine Elit
ORCID ID
Contact details
Juravinski Cancer Centre
Division of Gynecologic Oncology
699 Concession Street
Hamilton
L8V 5C2
Canada
+1 905 389 5688
laurie.elit@hrcc.on.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-38135
Study information
Scientific title
Acronym
Study hypothesis
The optimal management strategy for women with biopsy confirmed Cervical Intraepithelial Neoplasia 1 (CIN 1) is unclear. Our hypothesis is that a strategy of colposcopic follow up and treating progressive disease is as good as immediate treatment with Loop Electrosurgical Excision Procedure (LEEP).
Ethics approval
Ethics approval received from the McMaster University Research Ethics Board in December 2004.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Preinvasive Cervical Disease
Intervention
1. Colposcopic Follow up for 18 months
2. Immediate LEEP treatment
Trial details received: 12 Sept 2005
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Progression to CIN 2 or worse within 18 months.
Secondary outcome measures
1. Persistent CIN 1 at 18 months
2. Adverse events
3. Assess the following prognostic factors: persistent versus incident disease, lesion size, patients age, smoking, Human Papillomavirus (HPV) type and load
Overall trial start date
01/11/2000
Overall trial end date
30/09/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Documented CIN 1 by histologic assessment as the highest grade lesion present
2. Lesion confined to the cervix and completely visualized
3. Be 16 years or older, female
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
884
Participant exclusion criteria
Among patients satisfying the inclusion criteria the following will be excluding characteristics:
1. Index Pap smear showing CIN 2, 3 or cancer:
1.1. Index Pap smear shows atypical glandular cells of unknown significance, glandular dysplasia or malignancy requiring immediate investigation
1.2. Patients with previously identified CIN 1 by biopsy who are already in a surveillance program
2. 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
3. Pregnancy
4. Prior therapy for dysplasia including medical (5FU), surgical (Laser, LEEP) or cryotherapy
5. Prior gynecologic cancer
6. Prior pelvic radiation therapy
7. Inability to attend outpatient followup visits because of geographic inaccessibility
8. Other malignancies except non-melanoma skin cancer
9. Immunosuppression due to diseases such as Acquired Immune Deficiency Syndrome (AIDS), organ transplantation, or on immunosuppressive medications such as prednisone, imuran or chemotherapy for diseases like systemic lupus
10. Cognitively impaired or otherwise unable to obtain written informed consent
11. Extension of the CIN 1 lesion to vagina or a separate vaginal lesion showing dysplasia
12. Colposcopically visible condyloma outside of the transformation zone
13. Known allergy to local analgesics
14. Clinically evident vaginitis must be treated and resolved prior to entry on the trial
15. Inability to read and respond in English
16. Failure to provide informed consent
Recruitment start date
01/11/2000
Recruitment end date
30/09/2007
Locations
Countries of recruitment
Canada
Trial participating centre
Juravinski Cancer Centre
Hamilton
L8V 5C2
Canada
Sponsor information
Organisation
McMaster University (Canada) - Faculty of Health Sciences
Sponsor details
c/o Ms. Marie Townsend
Administrator
Research Programs
Office of the Associate Dean
1200 Main St. W.
Room HSC-3N8
Hamilton
L8N 3Z5
Canada
+1 905 525 9140 ext. 22465
hsresadm@mcmaster.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-38135)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary