Clinical trial NCT00935324: The Role of CK18F in Predicting Graft-Versus-Host Disease (GvHD)
Official title: CK18-Fragments as Tools for Evaluating Diagnosis, Biological Activity, and Prognosis of Graft-Versus-Host Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allo-SCT
Keywords: allo-SCT, GvHD, CK18-F
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: University of Regensburg
First posted: 2009-07-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for allo-SCT

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.

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:

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

Primary outcomes:
measure: Group A: Prediction of imminent GvHD Group B: To assess the levels of serum CK18-F
timeFrame: Group A: after allo-SCT for 1 years or until GvHD occures
Secondary outcomes:
measure: Response to therapy
timeFrame: 3, 7 and 14 days after start of immunosuppressive therapy for hepato-intestinal GvHD
measure: other serum markers such as sCD25, sCD40L, sFASL, sFAS, cytochrome C, sCD141 correlate with the achievement of complete responses
timeFrame: after allo-SCT for 1 year or until GvHD occurres
measure: CK18-F levels in the absence of a clinically diagnosed GvHD
timeFrame: after allo-SCT for one year
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg
Study officials:
affiliation: Heidelberg University
name: Thomas Luft, MD
role: PRINCIPAL_INVESTIGATOR
References: