NCT01672164已完成不适用
Discovery and Validation of Proteogenomic Biomarker Panels in a Prospective Serial Blood and Urine Monitoring Study of Liver Transplant Recipients - Transplant Proteogenomics
National Institute of Allergy and Infectious Diseases (NIAID)6 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2012年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 6
- 主要终点
- Acute Rejection
研究概览
简要总结
The main focus of this study is to develop blood and/or urine tests that will help to detect early signs of rejection in people who have had a liver transplant. Researchers will examine blood, urine, and tissue samples and try to identify markers for certain conditions such as rejection, response to therapy, and scarring of the liver. Additionally, researchers would like to identify biomarkers that can detect damage to the native kidneys before blood levels of creatinine rises. By studying gene expression, researchers hope to be able to diagnose these conditions earlier and improve liver survival.
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
- •Subjects undergoing primary deceased-donor or living donor liver transplantation;
- •Subject must be able to understand and provide informed consent.
排除标准
- •Need for combined organ transplantation;
- •Previous solid organ and/or islet cell transplantation;
- •Infection with HIV;
- •Allergy to iodine;
- •Inability or unwillingness of a participant to comply with study protocol;
- •Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
结局指标
主要结局
Acute Rejection
时间窗: 24 months after liver transplant
次要结局
- Recurrent Hepatitis-C Virus (HCV-R)(Baseline (Visit 1) to Month 24 (Visit 12))
- Protein expression profiles of plasma ( AR, HCV-R, CKD)(Baseline (Visit 1) to Month 24 (Visit 12))
- Multiparameter Flow Cytometry - Viral Pathogens(Baseline (Visit 1) to Month 24 (Visit 12))
- Chronic Kidney Disease(CKD)(Baseline (Visit 1) to Month 24 (Visit 12))
- mRNA expression profiles of peripheral blood (AR, HCV-R, CKD)(Baseline (Visit 1) to Month 24 (Visit 12))
- mRNA expression profiles of liver biopsies (AR, HCV-R)(Baseline (Visit 1) to Month 24 (Visit 12))
- Protein expression profiles of urine (CKD)(Baseline (Visit 1) to Month 24 (visit 12))
- microRNA Profiling Plasma & Cells(Baseline (Visit 1) to Month 24 (Visit 12))
- Severity of acute rejection(Baseline (Visit 1) to Month 24 (Visit 12):)
- Incidence of death, graft loss, and need for liver retransplantation(Baseline (Visit 1) to Month 24 (Visit 12))
- Incidence of opportunistic infections, malignancy, and cardiovascular complications(Baseline (Visit 1) to Month 24 (Visit 12))
- Viral Monitoring - EBV & CMV(Baseline (Visit 1) to Month 24 (Visit 12))
研究者
研究点 (6)
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