Clinical trial NCT00156026: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Intraepithelial Neoplasia
Keywords: CIN 1
cervical intraepithelial neoplasia
cervix
cancer
loop electrosurgical excision procedure
LEEP
expectant management
human papilloma virus
HPV
colposcopy
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-09-12
Enrollment: 415
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: progression to more advanced disease
timeFrame: 18 months
Secondary outcomes:
measure: persistent CIN 1 after 18 months
timeFrame: 18 months
measure: bleeding.
timeFrame: 18 months
measure: predict disease persistence or progression
timeFrame: 18 months
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Universidade Estadual de Campinas
city: Rio de Janeiro
country: Brazil
facility: Instituto Fernandes Figueira - Oswaldo Cruz Foundation
city: Vancouver
country: Canada
facility: B.C. Cancer Agency
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Cancer Centre
state: Nova Scotia
city: Brantford
country: Canada
facility: Brantford General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Henderson Site
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
city: Quebec
country: Canada
facility: Hôpital du Saint-Sacrement
Study officials:
affiliation: Juravinski Cancer Centre
name: Laurie Elit, MD
role: STUDY_CHAIR
affiliation: Ontario Clinical Oncology Group (OCOG)
name: Mark Levine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University, Dept of Clinical Epidemiology & Biostatistics
name: Jim Julian, MMath
role: PRINCIPAL_INVESTIGATOR
References: