Dendritic Cells in Patients Following Allogeneic Hematopo... | NCT00450268

Studies
Dendritic Cells in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation

NCT00450268

Sponsor

Technische Universität Dresden

Status

Unknown status

Last Update Posted

Mar 22, 2007Estimated

Enrollment

Phase

Not provided

Conditions

Graft Versus Host Disease

Interventions

blood draw, skin shave biopsy

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

Mar 2007

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

Jan 2005

Primary Completion Date

Not provided

Completion Date

Jan 2010Estimated

First Submitted Date

Mar 21, 2007

First Submission Date that Met QC Criteria

Mar 21, 2007

First Posted Date

Mar 22, 2007Estimated

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

Mar 21, 2007

Last Update Posted Date

Mar 22, 2007Estimated

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

We plan to investigate prospectively and simultaneously skin and blood DC subtypes, their donor/recipient origin and the correlation of DC reconstitution kinetics with treatment, clinical outcome and incidence of aGvHD in patients undergoing allogeneic hematopoietic stem cell transplantation.

Detailed Description

Blood and skin DC reconstitution shall be investigated in patients affected by hematological diseases and receiving HLA-matched, mobilized peripheral blood stem cells from related or unrelated donors. We plan to simultaneously collect and process double biopsies, i.e. from graft versus host disease affected and non-lesional skin of patients at onset of acute graft versus host disease following allogeneic hematopoietic stem cell transplantation. Emigration assay, Chimerism analysis and immunohistochemistry will be performed.

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

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
blood draw, skin shave biopsy	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient undergoing an allogeneic hematopoietic stem cell transplantation
Older than 18 years
WHO-Performance-Status 0 to3
Informed consent
Graft versus host disease of the skin

Exclusion Criteria:

Clotting parameters more than double of normal
Infection of the skin
Leucocytes < 1000/µl; Thrombocytes < 20 000/µl

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Susanne Gretzinger, MD	Contact	+49 351 458	2583	susanne.gretzinger@uniklinik-dresden.de
Martin Bornhäuser, Professor	Contact	*49 351 458	4190	martin.bormhaeuser@uniklinik-dresden.de

Overall Officials

Name	Affiliation	Role
Susanne Gretzinger, MD	Universität Carl Gustav Carus Med Klinik I	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinik Carl Gustav Carus	Recruiting	Dresden		01307	Germany

Condition Browse Module

MeSH Terms

ID	Term
D006086	Graft vs Host Disease

Ancestor Terms

ID	Term
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided