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Completed

NCT Number: NCT00009711

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

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.

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Key information

Conditions

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

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

management of therapy complications

Procedure

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

The Impact of Pediatric Marrow Transplantation on Late Pulmonary Function

Important dates

Study start
1996
Primary completion
2004
Study completion
2005
First posted
Jan 27, 2003
Registry last updated
May 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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