International Registry for Severe Chronic Neutropenia

• Conditions: Neutropenia

• Registration Number: NCT00004342
• Lead Sponsor: National Center for Research Resources (NCRR)

Brief Summary

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.

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.

Study Timeline

• Study Start: 1994-06
• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (10)

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; 🇩🇪 Hannover, Germany

Leeds Teaching Hospitals, Yorkshire Regional Centre for Paediatric Oncology & Haematology; 🇬🇧 Leeds, England, United Kingdom