Graft Versus Host DiseaseDCalloTXNCT00450268
Dendritic Cells in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation
An observational study of Graft Versus Host Disease, run by Technische Universität Dresden at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Versus Host Disease
- What is being tested?
- blood draw, skin shave biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2005to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Clotting parameters more than double of normal
- Infection of the skin
- Leucocytes < 1000/µl; Thrombocytes < 20 000/µl
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinik Carl Gustav Carus
Dresden, 01307
Susanne Gretzinger, MD, +49 351 458 ext. 2583, susanne.gretzinger@uniklinik-dresden.de
Martin Bornhaeuser, MD, +49 351 458 ext. 4190, Martin.Bornhaeuser@uniklinik-dresden.de
About this study
Official title: Analysis of Dendritic Cells in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation
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.
Read the 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.
- Conditions
- Graft Versus Host Disease
- Being tested
- blood draw, skin shave biopsy
- Keywords
- Graft versus host disease, Allogeneic hematpoietic stem cell transplantation
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood draw, skin shave biopsyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2007 (estimated)
- Study startJan 2005
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Susanne Gretzinger, MD, Principal investigator, Universität Carl Gustav Carus Med Klinik I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450268
- Sponsor's protocol ID
- EK208122001
- Acronym
- DCalloTX
- Status last verified
- Mar 2007
- First submitted
- 21 Mar 2007
- Last updated
- 22 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Dendritic Cells in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00450268
- Acronym / sponsor ID
- DCalloTX / EK208122001
- Conditions
- Graft Versus Host Disease
- Keywords
- Graft versus host disease, Allogeneic hematpoietic stem cell transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Jan 2010 (estimated)
- First posted
- 22 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Clotting parameters more than double of normal
- Infection of the skin
- Leucocytes < 1000/µl; Thrombocytes < 20 000/µl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood draw, skin shave biopsy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Gretzinger, MD principal investigator
Universität Carl Gustav Carus Med Klinik I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft Versus Host Disease, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susanne Gretzinger, MD (+49 351 458 ext. 2583, susanne.gretzinger@uniklinik-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2007.