Cervical Intraepithelial Neoplasia
Conditions
Keywords
CIN 1, cervical intraepithelial neoplasia, cervix, cancer, loop electrosurgical excision procedure, LEEP, expectant management, human papilloma virus, HPV, colposcopy
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).
Interventions
1\. loop electrosurgical excision procedure
Sponsors
Canadian Institutes of Health Research (CIHR)
Ontario Clinical Oncology Group (OCOG)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression to more advanced disease | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| persistent CIN 1 after 18 months | 18 months |
| bleeding. | 18 months |
| predict disease persistence or progression | 18 months |
Countries
Brazil, Canada
Outcome results
None listed