Condition category
Cancer
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
11/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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, patient’s 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

http://www.mcmaster.ca/

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

Publication citations

Additional files

Editorial Notes