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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 8, 2009
First Posted Date July 9, 2009
Last Update Posted Date July 9, 2009
Study Start Date February 2009
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2009)
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 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 8, 2009)
  • Response to therapy [ Time Frame: 3, 7 and 14 days after start of immunosuppressive therapy for hepato-intestinal GvHD ]
  • 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 ]
  • CK18-F levels in the absence of a clinically diagnosed GvHD [ Time Frame: after allo-SCT for one year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Group A (patients scheduled for allo-SCT): 5ml serum (~25 times), 7,5ml EDTA (~25 times) Group B (healthy volunteers): 30ml blood once
Sampling Method Non-Probability Sample
Study Population Patients scheduled for allo-SCT
Condition Allo-SCT
Intervention Not Provided
Study Groups/Cohorts
  • Group A: patients following allo-SCT
    Patients scheduled for allo-SCT fulfilling all inclusion criteria
  • Group B - healthy controls
    healthy voluntary blood donors
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 8, 2009)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2011
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00935324
Other Study ID Numbers HD/R-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Prof. Dr. Peter Dreger, University of Heidelberg, Germany
Original Responsible Party Same as current
Current Study Sponsor Heidelberg University
Original Study Sponsor Same as current
Collaborators University of Regensburg
Investigators
Principal Investigator: Thomas Luft, MD Heidelberg University
PRS Account Heidelberg University
Verification Date July 2009