NCT00156026已完成3 期
Randomized Trial of Immediate Treatment vs. Colposcopic Follow-up for Biopsy-Proven CIN 1
Ontario Clinical Oncology Group (OCOG)20 个研究点 分布在 2 个国家目标入组 415 人开始时间: 2000年11月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 415
- 试验地点
- 20
- 主要终点
- progression to more advanced disease
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
progression to more advanced disease
时间窗: 18 months
次要结局
- persistent CIN 1 after 18 months(18 months)
- bleeding.(18 months)
- predict disease persistence or progression(18 months)
研究者
研究点 (20)
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