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

Completed

• Conditions: Long-term Effects Secondary to Cancer Therapy in Children; Pulmonary Complications

• Registration Number: NCT00009711
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

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.

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 Timeline

• Study Start: 1996-03
• Study First Submitted: 2001-02-02
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-08
• Study Completion: 2005-08
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-29
• Last Update Posted: 2013-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States