Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-29 @ 2:43 AM
Study NCT ID:
NCT00450268
Status:
UNKNOWN
Last Update Posted:
2007-03-22
First Post:
2007-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dendritic Cells in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-03-21', 'studyFirstSubmitDate': '2007-03-21', 'studyFirstSubmitQcDate': '2007-03-21', 'lastUpdatePostDateStruct': {'date': '2007-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-22', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Graft versus host disease', 'Allogeneic hematpoietic stem cell transplantation'], 'conditions': ['Graft Versus Host Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient undergoing an allogeneic hematopoietic stem cell transplantation\n* Older than 18 years\n* WHO-Performance-Status 0 to3\n* Informed consent\n* Graft versus host disease of the skin\n\nExclusion Criteria:\n\n* Clotting parameters more than double of normal\n* Infection of the skin\n* Leucocytes \\< 1000/µl; Thrombocytes \\< 20 000/µl'}, 'identificationModule': {'nctId': 'NCT00450268', 'acronym': 'DCalloTX', 'briefTitle': 'Dendritic Cells in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Analysis of Dendritic Cells in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'EK208122001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'blood draw, skin shave biopsy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Susanne Gretzinger, MD', 'role': 'CONTACT', 'email': 'susanne.gretzinger@uniklinik-dresden.de', 'phone': '+49 351 458', 'phoneExt': '2583'}, {'name': 'Martin Bornhaeuser, MD', 'role': 'CONTACT', 'email': 'Martin.Bornhaeuser@uniklinik-dresden.de', 'phone': '+49 351 458', 'phoneExt': '4190'}, {'name': 'Susanne Gretzinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Martin Bornhaeuser, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Christian Thiede, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinik Carl Gustav Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'centralContacts': [{'name': 'Susanne Gretzinger, MD', 'role': 'CONTACT', 'email': 'susanne.gretzinger@uniklinik-dresden.de', 'phone': '+49 351 458', 'phoneExt': '2583'}, {'name': 'Martin Bornhäuser, Professor', 'role': 'CONTACT', 'email': 'martin.bormhaeuser@uniklinik-dresden.de', 'phone': '*49 351 458', 'phoneExt': '4190'}], 'overallOfficials': [{'name': 'Susanne Gretzinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universität Carl Gustav Carus Med Klinik I'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}}}}