Study Results
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Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
1994-06-30
Brief Summary
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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.
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Detailed Description
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Patients are treated by the referring physician as medically indicated. Clinical data are collected at baseline and then every 6 months.
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Adult Neutropenic Subject
Adult subjects with diagnosis of severe chronic neutropenia
No interventions assigned to this group
Minor Neutropenic Subject
Children under 18 years of age who are diagnosed with severe chronic neutropenia
No interventions assigned to this group
Parent of Minor Neutropenic Subjects
Parent of minor subjects (i.e., children under 18 years of age) who are diagnosed with severe chronic neutropenia
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. For subjects with presumed cyclic neutropenia, documentation of at least two neutrophil cycles is preferred. Documentation should include the nadirs with neutrophil counts of less than 200 followed by a clear increase in the counts generally to at least 500 to 1000 followed by a second nadir, usually expected to occur at about three weeks after the first nadir, i.e., cycling with a three week periodicity. Documentation with at least six weeks of counts and two expected nadirs is preferred.
Cases not showing clear oscillations will be categorized as congenital (if neutropenia or neutropenic complications appear to have occurred from birth) or idiopathic (if all symptoms in evidence point to an acquired disorder occurring after the first year of life).
3. Bone marrow aspiration consistent with the diagnosis of congenital, cyclic or idiopathic neutropenia. In all of these conditions, it is expected that the marrow aspirate evaluation at the time of neutropenia will show a deficiency of mature neutrophils. An exception is myelokathexis, a condition with large accumulations of neutrophils with pycnotic nuclei in the marrow. Bone marrow aspirates may show some dyspoiesis of the neutrophil lineage, but abnormalities of erythropoiesis or platelet formation are, in general, inconsistent with the diagnosis of SCN.
4. Normal cytogenetic evaluation. The only exception being cases of well documented severe congenital neutropenia with preferably previously documented normal cytogenetic evaluation will now be enrolled in the Registry at the time of evolution to leukemia.
5. History of recurrent infections (i.e., severe mouth ulcers, gingivitis and sinusitis).
6. Age greater than three months.
7. Independent of hematological parameters, subjects with the following diagnoses may be included: Shwachman-Diamond syndrome (SDS), glycogen storage disease type 1b (GSD1b), Barth syndrome, and Cohen's syndrome.
8. Subjects with moderately severe chronic neutropenia (i.e., ANC less than 1.0x109/L) and recurrent severe infections (i.e., deep tissue infections of subcutaneous areas, lungs, liver, etc.).
9. Immune neutropenia with positive anti-neutrophil antibodies meeting criteria in 1, 3, 5 and 6.
10. All SCN subjects originally enrolled in Amgen-sponsored SCN studies.
Exclusion Criteria
2. Primary myelodysplasia
3. Primary leukemia
4. Aplastic anemia
5. Known HIV disease
6. Systemic autoimmune diseases such as rheumatoid arthritis or systemic lupus erythematosus
7. Chemotherapy-induced neutropenia (within the last 5 years)
3 Months
ALL
No
Sponsors
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University of Washington
OTHER
National Center for Research Resources (NCRR)
NIH
Responsible Party
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David Chandler Dale
Professor of Medicine
Principal Investigators
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David Chandler Dale
Role: STUDY_CHAIR
University of Washington
Locations
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Dana-Farber/Boston Children¹s Cancer and Blood Disorders Center
Boston, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
St. Joseph's Children's Hospital
Paterson, New Jersey, United States
University of Washington School of Medicine
Seattle, Washington, United States
Monash University
Melbourne, Victoria, Australia
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Medizinische Hochschule Hannover
Hanover, , Germany
Leeds Teaching Hospitals, Yorkshire Regional Centre for Paediatric Oncology & Haematology
Leeds, England, United Kingdom
Countries
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Facility Contacts
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David Chandler Dale
Role: primary
Bonnie Paula Cham
Role: primary
Sally Kinsey, MD
Role: primary
References
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Dale DC, Bonilla MA, Boxer L, et al.: Development of AML/MDS in a subset of patients (PTS) with severe chronic neutropenia (SCN). Blood 84(10 suppl 1): 518a, 1994.
Guerra J, Withers DA, Boxer LM. Myb binding sites mediate negative regulation of c-myb expression in T-cell lines. Blood. 1995 Sep 1;86(5):1873-80.
Welte K, Dale D. Pathophysiology and treatment of severe chronic neutropenia. Ann Hematol. 1996 Apr;72(4):158-65. doi: 10.1007/s002770050156.
Kalra R, Dale D, Freedman M, Bonilla MA, Weinblatt M, Ganser A, Bowman P, Abish S, Priest J, Oseas RS, Olson K, Paderanga D, Shannon K. Monosomy 7 and activating RAS mutations accompany malignant transformation in patients with congenital neutropenia. Blood. 1995 Dec 15;86(12):4579-86.
Other Identifiers
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UW-730
Identifier Type: -
Identifier Source: secondary_id
199/11901
Identifier Type: -
Identifier Source: org_study_id
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