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

Primary Purpose

Long-term Effects Secondary to Cancer Therapy in Children, Pulmonary Complications

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
management of therapy complications
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Long-term Effects Secondary to Cancer Therapy in Children focused on measuring long-term effects secondary to cancer therapy in children, pulmonary complications

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fred Hutchinson Cancer Research Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
April 29, 2013
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00009711
Brief Title
Study of Lung Function in Children Who Have Undergone Bone Marrow Transplantation
Official Title
The Impact of Pediatric Marrow Transplantation on Late Pulmonary Function
Study Type
Observational

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
March 1996 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long-term Effects Secondary to Cancer Therapy in Children, Pulmonary Complications
Keywords
long-term effects secondary to cancer therapy in children, pulmonary complications

7. Study Design

Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
management of therapy complications

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean E. Sanders, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States

12. IPD Sharing Statement

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

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