Status:
UNKNOWN
The Role of CK18F in Predicting Graft-Versus-Host Disease (GvHD)
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
University of Regensburg
Conditions:
Allo-SCT
Eligibility:
All Genders
18+ years
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...
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 app...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00935324
Start Date
February 1 2009
End Date
May 1 2011
Last Update
July 9 2009
Active Locations (1)
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1
University of Heidelberg
Heidelberg, Germany, 69120