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

Heidelberg University120 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Allo-SCT

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Heidelberg

Heidelberg, Germany

RECRUITING

Outcomes

Primary Outcomes

Group A: Prediction of imminent GvHD Group B: To assess the levels of serum CK18-F

Time frame: Group A: after allo-SCT for 1 years or until GvHD occures

Secondary Outcomes

Response to therapy

Time frame: 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

Time frame: after allo-SCT for 1 year or until GvHD occurres

CK18-F levels in the absence of a clinically diagnosed GvHD

Time frame: after allo-SCT for one year

Central Contacts

Thomas Luft, MD

CONTACT

+49(0)6221142 Thomas.Luft@med.uni-heidelberg.de

Peter Dreger, MD

CONTACT

+49(0)622156 Peter.Dreger@med.uni-heidelberg.de

Data from ClinicalTrials.gov

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