Allo-SCT
Conditions
Keywords
allo-SCT, GvHD, CK18-F
Brief summary
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
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.
Interventions
None listed
Sponsors
University of Regensburg
Heidelberg University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Germany
Contacts
Primary ContactThomas Luft, MD
Backup ContactPeter Dreger, MD
Outcome results
None listed