NCT00009711

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 1996

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1996

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

May 1, 2013

Status Verified

April 1, 2013

Enrollment Period

8.4 years

First QC Date

February 2, 2001

Last Update Submit

April 29, 2013

Conditions

Long-term Effects Secondary to Cancer Therapy in ChildrenPulmonary Complications

Keywords

long-term effects secondary to cancer therapy in childrenpulmonary complications

Interventions

management of therapy complicationsPROCEDURE

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Study Officials

  • Jean E. Sanders, MD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2001

First Posted

January 27, 2003

Study Start

March 1, 1996

Primary Completion

August 1, 2004

Study Completion

August 1, 2005

Last Updated

May 1, 2013

Record last verified: 2013-04

Locations

US(1)