CK18-Fragments as Tools for Evaluating Diagnosis, Biological Activity, and Prognosis of Graft-Versus-Host Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Group A: Prediction of imminent GvHD Group B: To assess the levels of serum CK18-F
研究概览
简要总结
Prospective, within-subject controlled study on multiple subject groups to evaluate the meaning of CK18-fragments in the diagnosis, biological activity and prognosis of graft-versus-host disease (GvHD). Groups consist of patients scheduled for allogenic stem cell transplantation (allo-SCT) (Group A) and healthy voluntary blood donors (Group B).
详细描述
Given the difficulties in assessing diagnosis, severity and biological activity of GvHD by clinical means only, objective parameters for specific GvHD assessment are highly desirable. Criteria for appropriate GvHD biomarkers have recently been defined, thereby stating that suitable validated markers for monitoring of chronic GvHD are still lacking. CK18-F is the first marker that mirrors the pathogenetic endpoint of GvHD i.e. GvHD-induced apoptotic activity in critical epithelial organs (bowel and liver). It represents a new class of GvHD markers which are complementary to the previously recognized immune activation parameters and might thereby be valuable for establishing serological signatures diagnostic for GvHD. This marker may allow distinguishing active GvHD from irreversible end organ damage and other clinical conditions commonly observed after transplant.
The aim of this study is to evaluate if diagnostic and therapeutic decisions in the clinical management of hepato-intestinal GvHD may be based on the measurement of CK18-F levels.
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
- 是
入选标准
- •admission for allogenic SCT
- •age >= 18 years
- •ability of subject to understand character and individual consequences of this clinical trial
- •written informed consent
- •healthy male of female
- •age >= 18 years
- •ability of subject to understand character and individual consequences of this clinical trial
- •written informed consent
排除标准
- •no specific exclusion criteria
- •prolonged bleeding, hemorrhagic diathesis or other indications for clotting disorders in the medical history
- •prolonged or intense menses in females
- •any other current medical condition or previous disease which in the opinion of investigator may influence subject safety or interfere with the study objective
- •intake of any study drug
结局指标
主要结局
Group A: Prediction of imminent GvHD Group B: To assess the levels of serum CK18-F
时间窗: Group A: after allo-SCT for 1 years or until GvHD occures
次要结局
- other serum markers such as sCD25, sCD40L, sFASL, sFAS, cytochrome C, sCD141 correlate with the achievement of complete responses(after allo-SCT for 1 year or until GvHD occurres)
- Response to therapy(3, 7 and 14 days after start of immunosuppressive therapy for hepato-intestinal GvHD)
- CK18-F levels in the absence of a clinically diagnosed GvHD(after allo-SCT for one year)