National Longitudinal Cohort of Hematological Diseases-Large Granular Lymphocytic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 9,999
- 试验地点
- 1
- 主要终点
- Hematologic response
研究概览
简要总结
Hematological diseases are disorders of the blood and hematopoietic organs. The current hematological cohorts are mostly based on single-center or multi-center cases, or cohorts with limited sample size in China. There is a lack of comprehensive and large-scale prospective cohort studies in hematology.
The objectives of this study are to investigate the incidence and risk factors of large granular lymphocytic leukemia (LGLL) and to analyze the treatment effectiveness, patient prognosis, and healthcare costs in China.
- Analyze the demographic and clinical characteristics of patients with LGLL, including sex, age, disease severity, and other relevant factors.
- Examine disease features of LGLL patients, such as biochemical and hematological indicators, LGL counts, clonality, bone marrow pathology, and cytogenetics
- Assess treatment patterns and real-world effectiveness in LGLL patients.
- Evaluate clinical outcomes, including hematologic response, relapse, and mortality
- Investigate long-term prognosis, including post-discontinuation outcomes and health-related quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with LGLL.
- •Subjects treated at the Institute of Hematology and Blood Diseases Hospital from Jan 1, 2000.
排除标准
- •Subject unlikely to be available for long-term follow-up for any reason (e.g., inability to obtain follow-up data or presence of severe comorbidities).
- •Subject with alcohol or drug dependence that may reduce their compliance with the study.
- •Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study.
结局指标
主要结局
Hematologic response
时间窗: Assessments will be conducted at baseline, 6 months, 12 months, and 24 months after treatment, as well as at study completion, with an average interval of approximately 1 year.
Hematologic response contains improvements in neutrophil count, hemoglobin level, and platelet count
次要结局
未报告次要终点