Diagnostic and Therapeutic Value of Gut Microbiome in Adult Immune Thrombocytopenia
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- AUC value of 1-month drug resistance/relapse using baseline gut microbiota efficacy prediction model
研究概览
简要总结
Prospective, observational study to explore the significance of gut microbiome in the diagnosis of ITP, and to identify the predictive value of baseline gut microbiome for GC resistance/relapse.
详细描述
A prospective, observational study to (1) collect fecal samples from ITP patients at initial diagnosis (baseline) and after first-line GC treatment, (2) detect the composition of gut microbiome and related metabolites using metagenomic sequencing combined with metabolomics, (3) observe the impact of first-line treatment on gut microbiome, (4) explore the significance of gut microbiome in the diagnosis of ITP, and (5) identify the predictive value of baseline gut microbiome for GC resistance/relapse, thus to provide new ideas for clinical diagnosis and treatment of ITP.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older;
- •Isolated thrombocytopenia (platelet count of less than 100×10^9/L);
- •Normal leukocyte and erythrocyte counts according to routine blood tests;
- •Did not receive any medication for thrombocytopenia for 6 months.
排除标准
- •Secondary ITP such as drug-associated thrombocytopenia;
- •Thrombocytopenia caused by viral infection (HIV, Hepatitis B virus or Hepatitis C virus);
- •Nursing or pregnant women;
- •Severe dysfunction of the heart, kidney, lung or liver;
- •Active or previous malignancy;
- •Patients with other diseases were undergoing treatment with immunosuppressants;
- •Myelodysplastic disorder or myelofibrosis;
- •Patients who were undergoing first - or second-line therapy for thrombocytopenia within 6 months.
结局指标
主要结局
AUC value of 1-month drug resistance/relapse using baseline gut microbiota efficacy prediction model
时间窗: 1 month
The prediction model is constructed and calculated using machine learning methods
次要结局
- AUC value of 3-month drug resistance/relapse using baseline gut microbiota efficacy prediction model(3 months)
- AUC value of 6-month drug resistance/relapse using baseline gut microbiota(6 months)
- Duration of response(6 months)
- Time to response(6 months)
研究者
Xiao Hui Zhang
Vice president of Peking Univeristy Institute of Hematology
Peking University People's Hospital