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

Heidelberg University

Status

Unknown

Conditions

Allo-SCT

Study type

Observational

Funder types

Other

Identifiers

NCT00935324

HD/R-01

Details and patient eligibility

About

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).

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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