Study of Lung Function in Children Who Have Undergone Bon... | NCT00009711

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

NCT00009711

Sponsor

Fred Hutchinson Cancer Center

Status

Completed

Last Update Posted

May 1, 2013Estimated

Enrollment

280Estimated

Phase

Not provided

Conditions

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

Interventions

management of therapy complications

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1996

Primary Completion Date

Aug 2004Actual

Completion Date

Aug 2005Actual

First Submitted Date

Feb 2, 2001

First Submission Date that Met QC Criteria

Jan 26, 2003

First Posted Date

Jan 27, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2013

Last Update Posted Date

May 1, 2013Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

280Estimated

Name	Type	Description	Arm Group Labels	Other Names
management of therapy complications	Procedure

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Type	Description
FHCRC-1097.00
NCI-G00-1911
CDR0000065808	Registry Identifier	PDQ