Study of Lipopolysaccharide Metabolism for Identification of New Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 4
- 主要终点
- Area under the ROC curve for PLTP in the occurrence of GVHD
研究概览
简要总结
This study is designed to assess the hypothesis that the lipopolysaccharide (LPS) activity index can be quantified early after transplantation, as well as the the PhosphoLipid Transfer Protein (PLTP) activity and these both biological variables are independent variables for predicting the risk of severe Graft versus Host Disease (GVHD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hematologic malignancy in complete remission
- •Patients eligible for allogeneic hematopoietic cell transplantation from a related or unrelated donor and after myeloablative or non-myeloablative conditioning.
- •Regular follow-up in the center
排除标准
- •Treatment with a statin in progress
- •Umbilical cord blood transplantation
- •Hemoglobin level less than or equal to 8g / dl
- •Known chronic inflammatory bowel disease or gastroenteritis at the time of inclusion.
- •Chronic enteropathy with Clostridium Difficile
结局指标
主要结局
Area under the ROC curve for PLTP in the occurrence of GVHD
时间窗: 3 months
Area under the ROC curve (AUCROC) for PLTP assessed at day 0 (day of transplantation) in the occurrence of GVHD (grade II-IV) at 3 months post-transplant.
Area under the ROC curve for LPS in the occurrence of GVHD
时间窗: 3 months
Area under the ROC curve (AUCROC) for LPS assessed at day 0 (day of transplantation) in the occurrence of GVHD (grade II-IV) at 3 months post-transplant.
次要结局
未报告次要终点