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Sponsored by: |
European Working Group of MDS in Childhood |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00499070 |
RATIONALE: Studying biopsy, bone marrow, and blood samples from patients with cytopenia that did not respond to treatment may help doctors learn more about the disease and plan the best treatment.
PURPOSE: This laboratory study is assessing immune function in young patients with cytopenia that did not respond to treatment.
Condition | Intervention |
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Dyskeratosis Congenita Fanconi Anemia Myelodysplastic Syndromes Pearson Marrow-Pancreas Syndrome Precancerous/Nonmalignant Condition Shwachman-Diamond Syndrome |
Procedure: biopsy Procedure: flow cytometry Procedure: immunologic technique Procedure: polymerase chain reaction |
Study Type: | Observational |
Official Title: | TCR Vbeta Repertoire and PNH Clones in Children With Refractory Cytopenia (RC). An Open Nonrandomised Multi-Center Prospective Study |
Estimated Enrollment: | 125 |
Study Start Date: | January 2007 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter, nonrandomized, prospective study.
Patients undergo biopsy, bone marrow, and blood sample collection periodically for immunological studies. Samples are analyzed for TCR V beta repertoire and paroxysmal nocturnal hemoglobinuria (PNH) clone analysis via PCR heteroduplex analysis and immunophenotyping of CD14, CD16 , CD55, CD59, and CD24 expression via flow cytometry.
Ages Eligible for Study: | up to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of refractory cytopenia (RC) including any of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Austria | |
St. Anna Children's Hospital | Recruiting |
Vienna, Austria, A-1090 | |
Contact: Monika Trebo, MD 43-140-1700 | |
Belgium | |
Ghent University | Recruiting |
Ghent, Belgium, B-9000 | |
Contact: Barbara De Moerloose, MD, PhD 32-9332-6417 | |
Czech Republic | |
University Hospital Motol | Recruiting |
Prague, Czech Republic, 150 06 | |
Contact: Jan Stary, MD 420-2-2443-6401 jan.stary@lfmotol.cuni.cz | |
Denmark | |
Arhus Universitetshospital - Skejby | Recruiting |
Aarhus, Denmark, 8200 | |
Contact: Henrik Hasle, MD 45-8949-6716 hasle@dadlnet.dk | |
Germany | |
Universitaetskinderklinik - Universitaetsklinikum Freiburg | Recruiting |
Freiburg, Germany, D-79106 | |
Contact: Charlotte Niemeyer, MD 49-761-270-4506 charlotte.niemeyer@uniklinik-freiburg.de | |
Italy | |
Fondazione I.R.C.C.S. Policlinico San Matteo | Recruiting |
Pavia, Italy, 27100 | |
Contact: Marco Zecca, MD 39-38-250-2916 m.zecca@smatteo.pv.it | |
Netherlands | |
Erasmus MC - Sophia Children's Hospital | Recruiting |
Rotterdam, Netherlands, 3015 GJ | |
Contact: Marry M. Van Den Heuvel-Eibrink, MD, PhD 31-104-636-691 | |
Poland | |
Akademia Medyczna im. Piastow Slaskich | Recruiting |
Wroclaw, Poland, 50-345 | |
Contact: Dorota Wojcik, MD, PhD 48-71-733-1900 | |
Switzerland | |
University Children's Hospital | Recruiting |
Zurich, Switzerland, CH-8032 | |
Contact: Eva Bergstrasser, MD 41-44-266-7723 |
Study Chair: | Marry M. Van Den Heuvel-Eibrink, MD, PhD | Erasmus MC - Sophia Children's Hospital |
Study ID Numbers: | CDR0000553058, EWOG-MDS-RC-06, EU-20733 |
Study First Received: | July 10, 2007 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00499070 |
Health Authority: | Unspecified |
refractory cytopenia with multilineage dysplasia aplastic anemia Fanconi anemia |
dyskeratosis congenita Shwachman-Diamond syndrome Pearson marrow-pancreas syndrome |
Precancerous Conditions Shwachman-Diamond syndrome Pancrelipase Preleukemia Dyskeratosis congenita Fanconi's anemia Dyskeratosis Congenita Anemia, Aplastic Genetic Diseases, X-Linked Congenital Abnormalities Skin Diseases, Genetic Myelodysplastic syndromes Metabolic Diseases |
Skin Diseases Hematologic Diseases Fanconi Anemia Myelodysplastic Syndromes Myelodysplasia Skin Abnormalities Anemia Pearson's marrow-pancreas syndrome Shwachman syndrome Genetic Diseases, Inborn Bone Marrow Diseases Aplastic anemia Metabolic disorder |
Neoplasms Pathologic Processes Disease |
Anemia, Hypoplastic, Congenital Syndrome DNA Repair-Deficiency Disorders |