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

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

Randomized Trial of Immediate Treatment vs. Colposcopic Follow-up for Biopsy-Proven CIN 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00156026
• Other study ID #: OCOG-2000-CIN1
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: January 28, 2009
• Start date: November 2000
• Est. completion date: September 2007

Study information

• Verified date: January 2009
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia

Intervention

Procedure:
• loop electrosurgical excision procedure (LEEP)
1. loop electrosurgical excision procedure

Locations

Country	Name	City	State
Brazil	Universidade Estadual de Campinas	Campinas
Brazil	Instituto Fernandes Figueira - Oswaldo Cruz Foundation	Rio de Janeiro
Canada	Brantford General Hospital	Brantford	Ontario
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	Hamilton Health Sciences - Henderson Site	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Hôpital du Saint-Sacrement	Quebec
Canada	University of Saskatchewan	Saskatoon	Saskatchewan
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	B.C. Cancer Agency	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

Brazil,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression to more advanced disease		18 months	Yes
Secondary	persistent CIN 1 after 18 months		18 months	Yes
Secondary	bleeding.		18 months	Yes
Secondary	predict disease persistence or progression		18 months	No