MicroRNAs as Diagnostic and Predictive Biomarkers for Acute Graft Versus Host Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Identify plasma microRNA expression in stem cell transplant patients with acute graft versus host disease compared to controls.
研究概览
简要总结
The goal of this research proposal is to identify a miRNA expression profile as a biomarker to diagnose and predict acute graft versus host disease (aGVHD) in patients who undergo allogeneic transplantation. This biomarker, once identified, will need validation in larger cohorts.
详细描述
Human subjects that volunteer to participate in this study will be requested to have approximately 20 cc of blood drawn (about 12 tablespoons) at several time intervals. These time intervals include prior to conditioning regimen for transplant, the day of transplantation, day +30, +60 and +100 after transplantation. If a given subject develops acute graft-versus-host disease, a blood sample will be obtained at that time as well. The amount of blood samples collected in an 8 week period will not exceed 50 ml and collection will not occur more than twice a week. There will be no pregnant women or children involved in the investigators study.
All patients involved in the study will be undergoing bone marrow transplant and pregnancy screening is done in pre-transplant testing. This blood will be collected in lavender top, EDTA tubes; some plasma (or serum) may be collected and stored for additional analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 是
入选标准
- •Patients undergoing fully matched allogeneic PBCSC and bone marrow transplantation who present with clinical signs and symptoms of grade II- IV aGVHD within 100 days after transplantation as defined by skin, GI, and/or liver involvement that are confirmed by biopsy, regardless of age
- •Patients undergoing a matched, unrelated donor (8/8) or matched, related donor transplant (6/6)
- •Allogeneic transplant is from donor's peripheral blood stem cells or bone marrow transplant
- •Patients who develop grade II-IV aGVHD
排除标准
- •Patients who receive transplants from incompletely matched donors
- •Patients who receive T cell depleted transplants
- •Patients who receive haplo-identical transplants
- •Pregnant Patients
结局指标
主要结局
Identify plasma microRNA expression in stem cell transplant patients with acute graft versus host disease compared to controls.
时间窗: 24 months
次要结局
未报告次要终点