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Study of Lung Function in Children Who Have Undergone Bone Marrow Transplantation



Study of Lung Function in Children Who Have Undergone Bone Marrow Transplantation

For Condition: long-term effects secondary to cancer therapy in children,Pulmonary Complications
Status: No longer recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Assessing the long-term effects of bone marrow transplantation on lung function in patients may improve the ability to plan treatment. PURPOSE: Study to determine the long-term effects on lung function in children who have undergone bone marrow transplantation.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /17 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JeanSanders,  Study Chair,  Fred Hutchinson Cancer Research Center

Fred Hutchinson Cancer Research Center
Seattle,  Washington,  98109-1024
United States
 


Additional Information:
Study ID Numbers:
  CDR0000065808;  FHCRC-1097.00,NCI-G00-1911
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009711

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4. Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

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