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

Allo-SCT Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00935324
• Other study ID #: HD/R-01
• Status: Recruiting
• Phase: N/A
• First received: July 8, 2009
• Last updated: July 8, 2009
• Start date: February 2009
• Est. completion date: May 2011

Study information

• Verified date: July 2009
• Source: Heidelberg University
• Contact: Thomas Luft, MD
• Phone: +49(0)6221142
• Email: Thomas.Luft[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allo-SCT
• Graft vs Host Disease

Locations

Country	Name	City	State
Germany	University of Heidelberg	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Response to therapy		3, 7 and 14 days after start of immunosuppressive therapy for hepato-intestinal GvHD	Yes
Secondary	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	Yes
Secondary	CK18-F levels in the absence of a clinically diagnosed GvHD		after allo-SCT for one year	No