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

Tracking Information

First Received Date ^ICMJE

February 2, 2001

Last Updated Date

May 9, 2009

Start Date ^ICMJE

March 1996

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00009711 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Impact of Pediatric Marrow Transplantation on Late Pulmonary Function

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 Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Condition ^ICMJE

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

Intervention ^ICMJE

Procedure: management of therapy complications

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

280

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00009711

Responsible Party

Study ID Numbers ^ICMJE

CDR0000065808, FHCRC-1097.00, NCI-G00-1911

Study Sponsor ^ICMJE

Fred Hutchinson Cancer Research Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Jean E. Sanders, MD

Fred Hutchinson Cancer Research Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP