The Role of CK18F in Predicting Graft-Versus-Host Disease (GvHD)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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CK18-Fragments as Tools for Evaluating Diagnosis, Biological Activity, and Prognosis of Graft-Versus-Host Disease

Conditions
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Allo-SCT

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group A: admission for allogenic SCT age >= 18 years ability of subject to understand character and individual consequences of this clinical trial written informed consent Group B: healthy male of female age >= 18 years ability of subject to understand character and individual consequences of this clinical trial written informed consent Exclusion Criteria: Group A: no specific exclusion criteria Group B: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A: patients following allo-SCT<br>Patients scheduled for allo-SCT fulfilling all inclusion criteria | |
| Group B - healthy controls<br>healthy voluntary blood donors | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Group A: Prediction of imminent GvHD Group B: To assess the levels of serum CK18-F |  | Group A: after allo-SCT for 1 years or until GvHD occures | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to therapy |  | 3, 7 and 14 days after start of immunosuppressive therapy for hepato-intestinal GvHD | 
| 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 | 
| CK18-F levels in the absence of a clinically diagnosed GvHD |  | after allo-SCT for one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allo-SCT, GvHD, CK18-F