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Home > "I" Clinical Trials Conditions > International Registry for Severe Chronic Neutropenia  International Registry for Severe Chronic Neutropenia
International Registry for Severe Chronic Neutropenia
For Condition: Neutropenia
Status: Recruiting
Sponsor(s): National Center for Research Resources (NCRR) , University of Washington
Synopsis: OBJECTIVES: I. Document the clinical course of severe chronic neutropenia (SCN). II. Monitor and assess long term safety of primary treatment in SCN patients in the United States, Canada, Europe, and Australia. III. Study the incidence and outcome of adverse events such as osteoporosis, splenomegaly, cytogenetic abnormalities, myelodysplastic syndrome, and leukemia. IV. Evaluate growth and development and hematologic parameters. V. Monitor for clinically significant changes in primary treatment response over time. VI. Establish a physician network to increase the understanding of SCN. VII. Establish a demographic database to allow for future research.
Details: PROTOCOL OUTLINE: Patients are treated by the referring physician as medically indicated. Clinical data are collected at baseline and then every 6 months.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 3 Months/
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Severe chronic neutropenia (SCN), i.e.: Absolute neutrophil count less than 500/mm3 on 3 occasions within the last 3 months (less than 200/mm3 for cyclic neutropenia) Bone marrow aspirate consistent with SCN History of infection No drug induced neutropenia No myelodysplastic syndrome No aplastic anemia No thrombocytopenia or anemia unless due to Shwachman-Diamond syndrome or glycogen storage disease type IB Prior enrollment on Amgen SCN trials eligible Bone marrow aspiration within 1 year required Cytogenetic evaluation strongly suggested --Prior/Concurrent Therapy-- At least 5 years since prior chemotherapy --Patient Characteristics-- No rheumatoid arthritis No systemic lupus erythematosus No HIV seropositivity
Total Enrollment: 1000
Location and Contact Information:
Overall Study Official:
DavidDale, Study Chair, University of Washington
Central Highlands Oncology Program *Recruiting*
Ballarat, Victoria, 3350
Australia
Recruiting George Kannourakis 61-353-334811
Women's Hospital *Recruiting*
Ann Arbor, Michigan, 48109-0266
United States
Recruiting Laurence Boxer 734-764-7127
Medizinische Hochschule Hannover *Recruiting*
Hannover, , D-30625
Germany
Recruiting Karl Welte 0511-532-6710
St. Barnabas Medical Center *Recruiting*
Livingston, New Jersey, 07039
United States
Recruiting Mary Bonilla 973-322-2800
CancerCare Manitoba *Recruiting*
Winnipeg, Manitoba, R3E 0V9
Canada
Recruiting Bonnie Cham 204-787-4147
Istituto Giannina Gaslini *Recruiting*
Genova, , 16148
Italy
Recruiting Pier Mori 10-5636-331
St. James's Hospital *Recruiting*
Leeds, England, LS9 7TF
United Kingdom
Recruiting Sally Kinsey 113 243 31 44
Hospital for Sick Children *Recruiting*
Toronto, Ontario, M5G 1X8
Canada
Recruiting Melvin Freedman 416-813-6152
University of Washington School of Medicine *Recruiting*
Seattle, Washington, 98195
United States
Recruiting David Dale 206-543-7215
Additional Information:
Study ID Numbers: 199/11901; UW-730
Study Start Date: June 1994
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004342
Other Neutropenia Studies:
1. Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy
2. Cancer in Inherited Bone Marrow Failure Syndromes
3. Combination Chemotherapy in Treating Patients With Newly Diagnosed Metastatic Ewing's Sarcoma or Primitive Neuroectodermal Tumor
4. Treatment of neutropenic patients with fever who are suspected to have a gram positive infection (a specific kind of bacteria)
5. Peripheral Stem Cell Transplantation to Prevent Neutropenia in Patients Receiving Chemotherapy for Relapsed or Refractory Non-Hodgkin's Lymphoma
Related Studies:
Other Neutropenia Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
International Registry for Severe Chronic Neutropenia
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