CREEK is a Multicenter Retrospective Study to Understand the Clinical Characteristics, Treatment Pathway and Resource Utilization for Patients With Chronic Lymphocytic Leukemia in International Region.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,088
- 试验地点
- 1
- 主要终点
- To describe disease Characteristics
研究概览
简要总结
A Multicenter Retrospective Study to understand the clinical characteristics, treatment pathway and resource utilization for patients with chronic lymphocytic leukemia A retrospective, multi-centre, observational study to describe disease characteristics, treatment patterns, treatment-related outcomes, and resource utilization for Chronic Lymphocytic Leukemia (CLL) patients in multiple international regions
详细描述
CREEK is a retrospective, observational, registry-based study including patients with an incidental diagnosis of CLL and started treatment (1st line, 2nd line, or Subsequent lines of treatment) within the period between 01 June 2016 and 12 months before data collection as identified from the patient records (from participating hospitals across the GCC States and the International region countries) with at least 12 months of follow-up, after starting on treatment.
Moreover, the study will include a pilot cohort in the GCC as an exploratory objective to describe the clinical and patient characteristics for the treatment-naive CLL patient
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Primary diagnosis of Chronic Lymphocytic Leukemia (CLL)
- •Initiated CLL treatment (including 1st line, 2nd line, or Subsequent lines of treatment) within the period between 01 June 2016, and 12 months before data collection
- •For GCC pilot cohort patients: treatment-naive CLL patients diagnosed between 01 June 2016, and 12 months before data collection.
- •Available medical records at the participating site reflecting at least 12 months of follow-up after starting on treatment (except in the case of the participant death within one year following treatment initiation).
- •Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver was granted), according to local regulations.
- •Adult male or female ≥18 years old at the time of diagnosis or according to the age of majority as defined by local regulations).
排除标准
- •Failure to meet one or more of the inclusion criteria.
- •Any diagnosis of B-cell malignancies other than CLL.
- •Current or prior use of "acalabrutinib" treatment.
- •Currently/previously receiving treatment in an interventional clinical trial at the time of entry into this study for indications CLL.
结局指标
主要结局
To describe disease Characteristics
时间窗: 5 Years
To describe Staging of disease, Prognosis, Cytogenetics abnormalities and Immunogenetic analysis * Prognosis made by fluorescence in situ hybridization (FISH) * Immunogenetic analysis
To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients
时间窗: 5 Years
To describe the clinical characteristics for with chronic lymphocytic leukemia (CLL) patients, recording the patient characteristic: * Comorbidities. * Risk stratification
Calculation of Epidemiological Measure(s) of Interest
时间窗: 5 years
Calculation of Epidemiological Measure(s) of Interest e.g., descriptive statistics, hazard ratios, incidence rates, test/retest reliability)
次要结局
- Calculation of Epidemiological Measure(s) of Interest(5 Years)
- Recording the treatment patterns(5 years)
- Subsequent lines of therapies(5 Years)