The Role of CK18F in Predicting Graft-Versus-Host Disease... | NCT00935324

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

NCT00935324

Sponsor

Heidelberg University

Status

Unknown status

Last Update Posted

Jul 9, 2009Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Allo-SCT

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Mar 2011Estimated

Completion Date

May 2011Estimated

First Submitted Date

Jul 8, 2009

First Submission Date that Met QC Criteria

Jul 8, 2009

First Posted Date

Jul 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2009

Last Update Posted Date

Jul 9, 2009Estimated

Name	Class
University of Regensburg	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A: patients following allo-SCT		Patients scheduled for allo-SCT fulfilling all inclusion criteria
Group B - healthy controls		healthy voluntary blood donors

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Group A: Prediction of imminent GvHD Group B: To assess the levels of serum CK18-F		Group A: after allo-SCT for 1 years or until GvHD occures

Secondary Outcomes

Measure	Description	Time Frame
Response to therapy		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		after allo-SCT for 1 year or until GvHD occurres

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled for allo-SCT

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas Luft, MD	Contact	+49(0)6221142	3349	Thomas.Luft@med.uni-heidelberg.de
Peter Dreger, MD	Contact	+49(0)622156	8283	Peter.Dreger@med.uni-heidelberg.de

Overall Officials

Name	Affiliation	Role
Thomas Luft, MD	Heidelberg University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Heidelberg	Recruiting	Heidelberg		69120	Germany