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

NCT ID: NCT00935324

Last Updated: 2009-07-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2011-05-31

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.

Conditions

Allo-SCT

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A: patients following allo-SCT

Patients scheduled for allo-SCT fulfilling all inclusion criteria

No interventions assigned to this group

Group B - healthy controls

healthy voluntary blood donors

No interventions assigned to this group

Eligibility Criteria

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:

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Regensburg

OTHER

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

University of Heidelberg, Germany

Principal Investigators

Thomas Luft, MD

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

University of Heidelberg

Heidelberg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Thomas Luft, MD

Role: CONTACT

Thomas.Luft@med.uni-heidelberg.de

+49(0)6221142 ext. 3349

Peter Dreger, MD

Role: CONTACT

Peter.Dreger@med.uni-heidelberg.de

+49(0)622156 ext. 8283

Facility Contacts

Thomas Luft, MD

Role: primary

Thomas.Luft@med.uni-heidelberg.de

+49(0)622142 ext. 3349

Other Identifiers

HD/R-01

Identifier Type: -

Identifier Source: org_study_id