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International Registry for Severe Chronic Neutropenia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
University of Washington
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00004342
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: December 2003
  Purpose

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.


Condition
Neutropenia

Study Type: Observational
Study Design: Observational Model: Natural History

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 1000
Study Start Date: June 1994
Detailed Description:

PROTOCOL OUTLINE:

Patients are treated by the referring physician as medically indicated. Clinical data are collected at baseline and then every 6 months.

  Eligibility

Ages Eligible for Study:   3 Months and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004342

Locations
United States, Michigan
Women's Hospital
Ann Arbor, Michigan, United States, 48109-0266
United States, New Jersey
St. Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, Washington
University of Washington School of Medicine
Seattle, Washington, United States, 98195
Australia, Victoria
Central Highlands Oncology Program
Ballarat, Victoria, Australia, 3350
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Germany
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Italy
Istituto Giannina Gaslini
Genova, Italy, 16148
United Kingdom
St. James's Hospital
Leeds, England, United Kingdom, LS9 7TF
Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Washington
Investigators
Study Chair: David Chandler Dale University of Washington
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00004342     History of Changes
Other Study ID Numbers: 199/11901  UW-730 
Study First Received: October 18, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):
chronic neutropenia
disease-related problem/condition
hematologic disorders
neutropenia
rare disease
severe chronic neutropenia

Additional relevant MeSH terms:
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on December 06, 2016