Observational Study on the Diagnosis and Management of Chronic Lymphocytic Leukemia (CLL) in Italy by Gruppo Italiano Malattie EMatologiche Dell'Adulto (GIMEMA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12,500
- 试验地点
- 24
- 主要终点
- Describe the diagnosis and management of CLL patients
研究概览
简要总结
retrospective and prospective multicenter observational clinical and biological data collection from all patients with newly diagnosed CLL, SLL or MBL.
retrospective cohort: all cases with a diagnosis between January 1st 2010 and August 31th 2021.
prospective cohort: all patients with a diagnosis between September 1st 2021 and September 1st 2025.
详细描述
This is a retrospective and prospective multicenter observational study designed by the Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA). The study consists of clinical and biological data collection from all patients with newly diagnosed CLL, SLL or MBL (according to the WHO 2007 and 2018 diagnostic criteria). The retrospective part aims at including all cases followed at participating centers with a diagnosis between January 1st 2010 and August 31th 2021 (planned study initiation), while the prospective part will include all patients with a documented diagnosis of CLL, SLL or MBL between September 1st 2021 and September 1st 2025 by the first immunophenotypic/histological evaluation. The data is collected through electronic case report form accessible by the participating centers on a dedicated platform.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years at diagnosis
- •One of the following diagnoses that meet the international diagnostic criteria (iwCLL2018 and WHO2017)
- •Chronic lymphocytic leukemia (CLL)
- •Small lymphocytic lymphoma (SLL)
- •CLL-like monoclonal B-cell lymphocytosis (MBL)
- •Retrospective cohort: CLL/SLL/MBL diagnosis between January 1st 2010 and August 31th
- •Prospective cohort: CLL/SLL/MBL diagnosis between September 1st 2021 and September 1st,
- •Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable)
排除标准
- 未提供
结局指标
主要结局
Describe the diagnosis and management of CLL patients
时间窗: at 1 year for the prospective cohort and at 4 years for the retrospective cohort
evaluation of CLL management in terms of time to first treatment
次要结局
未报告次要终点
