- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00009711
Study of Lung Function in Children Who Have Undergone Bone Marrow Transplantation
The Impact of Pediatric Marrow Transplantation on Late Pulmonary Function
RATIONALE: Assessing the long-term effects of bone marrow transplant on lung function in patients may improve the ability to plan treatment.
PURPOSE: This clinical trial studies lung function in pediatric patients who have undergone bone marrow transplant.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the delayed effects of bone marrow transplantation preparative regimens on pulmonary function in children surviving at least 5 years after transplantation for hematologic malignancy.
- Determine the relationship between pulmonary function and growth rates in these patients.
- Determine the effect of growth hormone treatment on pulmonary function in these patients.
- Determine the relationship between pulmonary function and age at time of transplantation in these patients.
- Determine the incidence and severity of restrictive pulmonary disease, and whether these factors vary with increasing time after transplantation in these patients.
OUTLINE: Patients undergo respiratory history, signs and symptoms assessment, pulmonary function tests (PFT) including spirometry, lung volumes, and diffusion, oxygen saturation by pulse oximetry, and height measurement.
Patients are assessed at 5-10 years, 10-15 years, and over 15 years after bone marrow transplantation. Patients with abnormal PFTs are assessed at more frequent intervals as clinically indicated.
PROJECTED ACCRUAL: Approximately 280 patients will be accrued for this study.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109-1024
- Fred Hutchinson Cancer Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Patients who have undergone bone marrow transplantation for hematologic malignancy at least 5 years ago
- Disease-free survivors at least 6 years of age AND
- Under 18 years of age at time of transplantation
- Received prior allogeneic, unrelated donor, syngeneic, or autologous bone marrow transplantation
- Able to perform pulmonary function tests
PATIENT CHARACTERISTICS:
Age:
- See Disease Characteristics
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- Any prior preparative regimen allowed
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1097.00
- FHCRC-1097.00
- NCI-G00-1911
- CDR0000065808 (Registry Identifier: PDQ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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