A Prospective, Multi-center, Cohort Study in Newly Diagnosed Marginal Zone B-cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Describe the clinical features, diagnosis and treatment status, disease course and primary outcomes of different subtypes of marginal zone B-cell lymphoma (MZL), observe the therapeutic efficacy and safety of different treatment modalities.
详细描述
Marginal zone lymphoma (MZL) originates from the marginal zone of lymphatic follicles and can occur in the spleen, lymph nodes and mucosal lymphoid tissues, and the incidence increases with age. The clinicopathological features of each subtype of MZL are heterogeneous, and their clinical manifestations, biology, etiology, and treatment are all quite heterogeneous, and there is still significant uncertainty about the optimal treatment pathway. This prospective, multicenter, cohort study aims to describe the clinical features, diagnosis and treatment status, disease course and primary outcomes of different subtypes of MZL, and to observe the therapeutic efficacy and safety of different treatment modalities.
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 old; Male or female.
- •Newly diagnosed marginal zone lymphoma by histopathology within the past 6 months (180 days) and no anti-tumor therapy (including chemotherapy, radiotherapy, and biological therapy or immunotherapy for the treatment of tumors).
- •Willing to provide biological samples required for the study, including blood samples and tumor tissue.
- •Voluntarily join this study and sign the informed consent form.
- •Willing to accept long-term follow-up.
排除标准
- •Patients with HIV infection.
- •Those who cannot come to the hospital regularly for follow-up.
- •Those with comorbidities and speech impairment.
结局指标
主要结局
Progression-free survival
时间窗: assessed up to 10 years
record the period from date of patients sign informed consent until the date of documented progression or date of death from any cause, whichever came first
次要结局
- Time to next treatment(assessed up to 10 years)
- Occurrence rate of a second tumor(Throughout the study, up to 10 years)
- Time to treatment(assessed up to 10 years)
- ORR(up to 6 months)
- Adverse events(Throughout the treatment period, up to 10 years)
- Overall survival(assessed up to 10 years)
- Histologic transformation rate(Throughout the study, up to 10 years)