NCT05950490招募中不适用
Construction of Diagnosis and Treatment System for Primary Vitreoretinal Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Interleukin-10/Interleukin-6（IL-10/IL-6）
研究概览
简要总结
This study intends to apply for the establishment of research beds, establish a Chinese PVRL research cohort, and carry out a to achieve the following research objectives:
The goal of this prospective observational study is to construct the diagnosis and treatment system for primary vitreoretinal lymphoma（PVRL）. The study is to achieve the following research objectives:
- To establish a comprehensive diagnostic criteria for PVRL with high diagnostic efficiency and strengthen the PVRL diagnostic system;
- To establish a standardized treatment pathway for PVRL and evaluate the efficacy and safety of treatment;
- To screen the prognosis evaluation indicators, and to establish the follow-up process and prognosis evaluation system of PVRL；
- To explore the pathogenesis of PVRL, specific tumor markers and drug therapeutic targets.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newly diagnosed PVRL patients admitted to the Ophthalmology or Hematology departments of Peking Union Medical College Hospital from 2022 to 2024;
- •18-75 years old;
- •The diagnosis was confirmed by pathology, aqueous humor/vitreous IL-10/IL-6, vitreous flow cytometry and gene rearrangement.;
- •HIV-Ab negative;
- •Creatinine clearance > 50ml/min;
- •Sign informed consent.
排除标准
- •Combined with other tumors;
- •Uncontrolled active infections;
- •Pregnant or lactating women;
- •Antitumor therapy other than the protocol of this study was used.
研究组 & 干预措施
Group A
Cerebrospinal fluid IL-10 was normal
干预措施: Intravitreal injection of methotrexate (Drug)
Group B
Cerebrospinal fluid IL-10 was normal or elevated
干预措施: Intravitreal injection of methotrexate (Drug)
结局指标
主要结局
Interleukin-10/Interleukin-6（IL-10/IL-6）
时间窗: 2.5 years
cerebrospinal
次要结局
未报告次要终点
研究者
研究点 (1)
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