Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009711
Status:
COMPLETED
Last Update Posted:
2013-05-01
First Post:
2001-02-02
Brief Title:
Study of Lung Function in Children Who Have Undergone Bone Marrow Transplantation
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
The Impact of Pediatric Marrow Transplantation on Late Pulmonary Function
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FHCRC-109700 | None | None | None |
| NCI-G00-1911 | None | None | None |
| CDR0000065808 | REGISTRY | PDQ | None |