International Registry for Severe Chronic Neutropenia

The recruitment status of this study is unknown because the information has not been verified recently.
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
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 Recruiting
Ann Arbor, Michigan, United States, 48109-0266
Contact: Laurence A. Boxer    734-764-7127      
United States, New Jersey
St. Barnabas Medical Center Recruiting
Livingston, New Jersey, United States, 07039
Contact: Donna Mura    973-322-8076    dmura@sbhcs.com   
United States, Washington
University of Washington School of Medicine Recruiting
Seattle, Washington, United States, 98195
Contact: David Chandler Dale    206-543-7215      
Australia, Victoria
Central Highlands Oncology Program Recruiting
Ballarat, Victoria, Australia, 3350
Contact: George Kannourakis    61-353-334811      
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Bonnie Paula Cham    204-787-4147      
Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Melvin H. Freedman    416-813-6152      
Germany
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, D-30625
Contact: Karl Welte    0511-532-6710      
Italy
Istituto Giannina Gaslini Recruiting
Genova, Italy, 16148
Contact: Pier G. Mori    10-5636-331      
United Kingdom
St. James's Hospital Recruiting
Leeds, England, United Kingdom, LS9 7TF
Contact: Sally Kinsey    113 243 31 44      
Sponsors and Collaborators
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
Hematologic Diseases
Leukocyte Disorders
Leukopenia

ClinicalTrials.gov processed this record on October 23, 2014