The Role of Cytokines in Early Diagnosis, Assessment of Response and Prognosis of Patients With Lymphoma-associated Hemophagocytic Lymphohistiocytosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The sensitivity and specificity of cytokines to predict lymphoma-associated HLH
研究概览
简要总结
Lymphoma-associated hemophagocytic lympohistiocytosis is a refractory immune disorder with high mortality. Early identification and diagnosis of lymphoma-associated HLH has become the key to improve the prognosis of lymphoma-associated HLH. Therefore, we conduct a multicenter, prospective, observational clinical study to explore the sensitivity and specificity of cytokines for the early diagnosis of lymphoma-associated HLH.
详细描述
Lymphoma-associated hemophagocytic lympohistiocytosis is a refractory immune disorder with high mortality. Without early intervention, the median survival time is less than 2 months. Early identification and diagnosis of lymphoma-associated HLH has become the key to improve the prognosis of lymphoma-associated HLH. Therefore, it is urgent to find a method for the early diagnosis of lymphoma-associated HLH. We conduct a multicenter, prospective, observational clinical study to explore the sensitivity and specificity of cytokines for the early diagnosis of lymphoma-associated HLH, and its correlation with disease severity, treatment response, and prognosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-75, gender is not limited.
- •Patients with histopathologically confirmed lymphoma who meet HLH-04 diagnostic criteria, and did not receive systemic chemotherapy before enrollment.
- •Patients with histopathologically confirmed lymphoma who did not receive systemic chemotherapy before enrollment.
- •Informed consent obtained.
排除标准
- •Patients with severe active infections (viral, bacterial, fungal, or parasitic).
- •Patients with active autoimmune disease or a history of organ transplantation who are receiving immunosuppressive therapy.
- •Patients with other type of malignant tumors within 5 years, except for cured solid tumors.
- •Patients planned to receive immunotherapy.
- •Pregnant and breastfeeding females.
- •History of human immunodeficiency virus (HIV) infection.
- •Acute or chronic active hepatitis B or hepatitis C.
- •Patients assessed as ineligible for the study by the investigator.
结局指标
主要结局
The sensitivity and specificity of cytokines to predict lymphoma-associated HLH
时间窗: 1 year
The sensitivity and specificity of cytokines as a means of early diagnosis of lymphoma-associated hemophagocytic lymphohistiocytosis
次要结局
- Dynamic changes of cytokine levels during treatment(1 years)
研究者
Zhao Wang
Professor and Head of hematology
Beijing Friendship Hospital