Plasma Biomarkers of Acute Graft Versus Host Disease

急性移植物抗宿主病的血浆生物标志物

• 批准号: 8424381
• 负责人: JAMES L. M. FERRARA
• 金额: $ 20.71万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-01 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8424381
• 关键词: Acute Graft Versus Host Disease; Aftercare; Algorithms; Allogeneic Bone Marrow Transplantation; Allogenic; Biological Markers; Clinical; Clinical Trials; Complication; Diagnostic; Diagnostic tests; IL2RA gene; IL8 gene; Laboratories; Measures; Newly Diagnosed; PI3 gene; Patients; Phase II Clinical Trials; Phase III Clinical Trials; Plasma; Randomized; Sampling; Serum; TNFRSF1A gene; Testing; Treatment outcome; Validation; graft vs host disease; hematopoietic cell transplantation; mortality; public health relevance; response; treatment duration; treatment response

DESCRIPTION (provided by applicant): Acute graft-versus-host disease (GVHD) is the primary limitation of allogeneic hematopoietic cell transplantation (HCT). There are currently no reliable diagnostic tests to predict the outcome of treatment, which correlate to long term survival. We have recently evaluated six previously validated diagnostic biomarkers of GVHD (IL2R?, TNFR1, HGF, IL8, elafin, and REG3?, for their ability to predict which patients would respond to therapy and who would achieve long term survival. We measured biomarker concentrations by from samples prospectively obtained at the initiation of treatment and day 28 following treatment in 112 patients who participated in a multicenter, randomized phase II clinical trial for newly diagnosed acute GVHD. We discovered an algorithm using values from all six biomarkers that predicted both day 28 response to treatment and mortality at day 180 from onset. This project will validate that algorithm by measuring all six biomarkers in a second group of 200 patients who patients who have recently participated in a multicenter, randomized phase II clinical trial for newly diagnosed acute GVHD. Awe will also develop a new algorithm by including a seventh biomarker that also predicts for response to treatment for GVHD. This algorithm will include both responses to treatment on day 28 after initiation of treatment as well as mortality at day 180 from the initiation of treatment.

描述（由申请人提供）：急性移植 - 抗宿主病（GVHD）是同种异体造血细胞移植（HCT）的主要局限性。目前尚无可靠的诊断测试来预测治疗结果，这与长期生存有关。我们最近评估了GVHD的六个先前验证的诊断生物标志物（IL2R？，TNFR1，HGF，HGF，IL8，Elafin和Reg3？），以预测哪些患者对治疗的响应以及谁将实现长期生存能力的响应。我们通过在AS次培训中获得的样本中的样本进行了二次治疗的次数，并在112次培训中获得的样本进行了28次培训，该样本在A 28阶段进行了28日28日的生存阶段。新诊断的急性GVHD的临床试验使用了所有六个生物标志物的算法，这些算法预测了第28天对治疗和死亡率的反应。通过包括第七个生物标志物，该算法还可以预测对GVHD治疗的响应。该算法将包括在治疗开始后第28天对治疗的反应，以及第180天的死亡率。