Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-03-02 @ 5:18 PM
Study NCT ID:
NCT00898118
Status:
UNKNOWN
Last Update Posted:
2013-08-12
First Post:
2009-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying Blood Samples in Young Patients With Cytopenia After a Donor Stem Cell Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D005434', 'term': 'Flow Cytometry'}], 'ancestors': [{'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002469', 'term': 'Cell Separation'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003592', 'term': 'Cytophotometry'}, {'id': 'D005470', 'term': 'Fluorometry'}, {'id': 'D008163', 'term': 'Luminescent Measurements'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'lastUpdateSubmitDate': '2013-08-09', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with complete chimerism as measured by standard short tandem nucleotide polymorphism PCR in whole blood and the different cell populations'}, {'measure': 'Number of patients with complete chimerism as measured by single nucleotide polymorphisms PCR in the different cell populations'}], 'secondaryOutcomes': [{'measure': 'Number of patients with mixed chimerism and full hematological recovery at day 100'}, {'measure': 'Number of patients with mixed chimerism and acute or chronic graft-versus-host disease'}]}, 'conditionsModule': {'keywords': ['refractory cytopenia with multilineage dysplasia', 'childhood myelodysplastic syndromes', 'previously treated myelodysplastic syndromes', 'secondary myelodysplastic syndromes'], 'conditions': ['Leukemia', 'Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.\n\nPURPOSE: This research study is looking at blood samples in young patients with cytopenia after undergoing a donor stem cell transplant.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To study hematopoietic chimerism in whole blood and different cell populations (i.e., CD14, CD15, CD 56, CD3, and CD19) as well as in dendritic cells and regulatory T cells after allogeneic hematopoietic stem cell transplantation with reduced intensity conditioning in patients with refractory cytopenia.\n* To compare the results of chimerism obtained with standard short tandem nucleotide polymorphism PCR (sensitivity 1%) with those obtained with single nucleotide polymorphisms PCR (sensitivity 0.1- 0.01%).\n\nSecondary\n\n* To evaluate the relationship between mixed chimerism and hematological engraftment, overall survival, and event-free survival.\n* To study the impact of mixed chimerism in plasmacytoid dendritic and regulatory T cells on the incidence of acute and chronic graft-versus-host-disease.\n\nOUTLINE: This is a multicenter study.\n\nPeripheral blood is collected from patients and donors prior to hematopoietic stem cell transplantation (HSCT). Patients also undergo blood sample collection on days 30, 60, 100, and 180 after transplantation. Peripheral blood cells are enriched and separated into lineage-specific subpopulations (i.e., CD3, CD14, CD15, CD19, and CD56) which are then divided equally for either DNA isolation via PCR or for flow cytometry. DNA concentrations in pre-HSCT donor and patient samples and in post-HSCT subpopulation samples are determined using quantitative real-time PCR. Samples are also analyzed for quantification of chimerism and detection of genetic markers via short tandem repeats- and sequence nucleotide polymorphism-based chimerism analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosed with refractory cytopenia\n\n * Hypocellular bone marrow and normal karyotype\n* Underwent stem cell transplantation (SCT) from an HLA identical (8/8) sibling, an HLA identical (10/10) relative, or an HLA identical or single allelic disparate unrelated donor\n\n * Received a preparative regimen including either thiotepa or fludarabine phosphate\n* Concurrently enrolled on EWOG-MDS-2006\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00898118', 'briefTitle': 'Studying Blood Samples in Young Patients With Cytopenia After a Donor Stem Cell Transplant', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Serial Analysis of Chimerism in Patients With Refractory Cytopenia (RC) Transplanted With Reduced Intensity Conditioning (RIC)', 'orgStudyIdInfo': {'id': 'EWOG-MDS-SCT RC RIC-06'}, 'secondaryIdInfos': [{'id': 'CDR0000587523', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'EU-20808'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'polymerase chain reaction', 'type': 'GENETIC'}, {'name': 'flow cytometry', 'type': 'OTHER'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}, {'name': 'allogeneic hematopoietic stem cell transplantation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'email': 'trebo@ccri.univie.ac.at', 'phone': '43-1-401-700'}], 'facility': "St. Anna Children's Hospital", 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'B-9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'email': 'barbara.demoerloose@ugent.be', 'phone': '32-9240-3875'}], 'facility': 'Ghent University', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '150 06', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'email': 'jan.stary@lfmotol.cuni.cz', 'phone': '42-022-443-6401'}], 'facility': 'University Hospital Motol', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': 'DK-8000', 'city': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'email': 'hasle@dadlnet.dk', 'phone': '45-8949-6841'}], 'facility': 'Aarhus Universitetshospital - Aarhus Sygehus', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact', 'role': 'CONTACT', 'email': 'Peter.Bader@kgu.de', 'phone': '49-761-270-4617'}], 'facility': 'European Working Group of MDS in Childhood', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': 'D-79106', 'city': 'Freiburg im Breisgau', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'email': 'ewog-mds@uniklini-freiburg.de', 'phone': '49-761-270-4506'}], 'facility': 'Universitaetskinderklinik - Universitaetsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '71013', 'city': 'South Giovanni Rotondo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact person', 'role': 'CONTACT', 'email': 'm.zecca@smatteo.pv.it', 'phone': '39-038-250-1251'}], 'facility': 'IRCCS "Casa Sollievo della Sofferenza"'}, {'zip': '3015 GJ', 'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'email': 'm.vandenheuvel@erasmusmc.nl', 'phone': '31-104-636-691'}], 'facility': "Erasmus MC - Sophia Children's Hospital", 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '50-367', 'city': 'Wroclaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'email': 'wojcikd@pedhemat.am.wroc.pl', 'phone': '48-71-328-2040'}], 'facility': 'Akademia Medyczna im. Piastow Slaskich', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': 'CH-8032', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'email': 'eva.bergstraesser@kispi.unizh.ch', 'phone': '41-44-266-7723'}], 'facility': "University Children's Hospital", 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Peter Bader, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Working Group of MDS in Childhood'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Working Group of MDS in Childhood', 'class': 'OTHER'}}}}