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

• Conditions: Allo-SCT

• Registration Number: NCT00935324
• Lead Sponsor: Heidelberg University

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.

Study Timeline

• Study Start: 2009-02
• Status Verified: 2009-07
• Study First Submitted: 2009-07-08
• Study First Submitted QC: 2009-07-08
• Last Update Submitted: 2009-07-08
• Study First Posted: 2009-07-09
• Last Update Posted: 2009-07-09
• Primary Completion: 2011-03
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of Heidelberg; 🇩🇪 Heidelberg, Germany