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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Cervical Intraepithelial Neoplasia

Intervention / Treatment
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* Procedure: loop electrosurgical excision procedure (LEEP)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Immediate Treatment - LEEP - Loop electrosurgical excision procedure | Procedure: loop electrosurgical excision procedure (LEEP)<br>* 1. loop electrosurgical excision procedure<br>|
| No Intervention: 2<br>Colposcopic Follow-up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression to more advanced disease |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| persistent CIN 1 after 18 months |  | 18 months | 
| bleeding. |  | 18 months | 
| predict disease persistence or progression |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CIN 1, cervical intraepithelial neoplasia, cervix, cancer, loop electrosurgical excision procedure, LEEP, expectant management, human papilloma virus, HPV, colposcopy