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

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ClinicalTrials.gov Identifier: NCT00935324
Recruitment Status : Unknown
Verified July 2009 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : July 9, 2009
Last Update Posted : July 9, 2009
Sponsor:
Collaborator:
University of Regensburg
Information provided by:
Heidelberg University

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).

Condition or disease
Allo-SCT

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.


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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CK18-Fragments as Tools for Evaluating Diagnosis, Biological Activity, and Prognosis of Graft-Versus-Host Disease
Study Start Date : February 2009
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Group/Cohort
Group A: patients following allo-SCT
Patients scheduled for allo-SCT fulfilling all inclusion criteria
Group B - healthy controls
healthy voluntary blood donors



Primary Outcome Measures :
  1. Group A: Prediction of imminent GvHD Group B: To assess the levels of serum CK18-F [ Time Frame: Group A: after allo-SCT for 1 years or until GvHD occures ]

Secondary Outcome Measures :
  1. Response to therapy [ Time Frame: 3, 7 and 14 days after start of immunosuppressive therapy for hepato-intestinal GvHD ]
  2. other serum markers such as sCD25, sCD40L, sFASL, sFAS, cytochrome C, sCD141 correlate with the achievement of complete responses [ Time Frame: after allo-SCT for 1 year or until GvHD occurres ]
  3. CK18-F levels in the absence of a clinically diagnosed GvHD [ Time Frame: after allo-SCT for one year ]

Biospecimen Retention:   Samples With DNA
Group A (patients scheduled for allo-SCT): 5ml serum (~25 times), 7,5ml EDTA (~25 times) Group B (healthy volunteers): 30ml blood once


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for allo-SCT
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935324


Contacts
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Contact: Thomas Luft, MD +49(0)6221142 ext 3349 Thomas.Luft@med.uni-heidelberg.de
Contact: Peter Dreger, MD +49(0)622156 ext 8283 Peter.Dreger@med.uni-heidelberg.de

Locations
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Germany
University of Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Thomas Luft, MD    +49(0)622142 ext 3349    Thomas.Luft@med.uni-heidelberg.de   
Sponsors and Collaborators
Heidelberg University
University of Regensburg
Investigators
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Principal Investigator: Thomas Luft, MD Heidelberg University

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Responsible Party: Prof. Dr. Peter Dreger, University of Heidelberg, Germany
ClinicalTrials.gov Identifier: NCT00935324     History of Changes
Other Study ID Numbers: HD/R-01
First Posted: July 9, 2009    Key Record Dates
Last Update Posted: July 9, 2009
Last Verified: July 2009

Keywords provided by Heidelberg University:
allo-SCT, GvHD, CK18-F

Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases