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

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

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).

Study Overview

• Status: Unknown
• Conditions: Allo-SCT

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • University of Heidelberg
    • Contact: Thomas Luft, MD; Phone Number: 3349 +49(0)622142; Email: Thomas.Luft@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for allo-SCT

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group A: patients following allo-SCT; Patients scheduled for allo-SCT fulfilling all inclusion criteria
Group B - healthy controls; healthy voluntary blood donors

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Heidelberg University
• Collaborators: University of Regensburg
• Investigators: Principal Investigator: Thomas Luft, MD, Heidelberg University

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Anticipated): March 1, 2011
• Study Completion (Anticipated): May 1, 2011

Study Registration Dates

• First Submitted: July 8, 2009
• First Submitted That Met QC Criteria: July 8, 2009
• First Posted (Estimate): July 9, 2009

Study Record Updates

• Last Update Posted (Estimate): July 9, 2009
• Last Update Submitted That Met QC Criteria: July 8, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: allo-SCT, GvHD, CK18-F
• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: HD/R-01