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

April 29, 2013 updated by: Fred Hutchinson Cancer Center

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

Completed

Conditions

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

Observational

Enrollment (Anticipated)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1996

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

February 2, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

May 1, 2013

Last Update Submitted That Met QC Criteria

April 29, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

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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