NCT00771836

Brief Summary

Background: Stem cell transplantation (SCT) is associated with pulmonary complications and may lead to high morbidity and mortality. We encountered several children post-SCT with a clinical picture suggestive of airway hyper-reactivity (AHR) and evidence of reversible airway obstruction that was not reported pre-transplant. Our aim was to determine if SCT induced AHR as assessed by methacholine challenge test (MCT) and to determine any correlation between AHR and pulmonary complications. Methods: Prospective study evaluating consecutive patients referred for SCT to the Department of Pediatric Hemato-Oncology at Meyer Children's Hospital. Evaluation included pulmonary function test and methacholine challenge test before and after the transplantation, and assessment of pulmonary complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2004

Typical duration 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

July 1, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2008

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 15, 2008

Completed
Last Updated

October 15, 2008

Status Verified

October 1, 2008

Enrollment Period

3 years

First QC Date

May 27, 2008

Last Update Submit

October 14, 2008

Conditions

Cancer

Keywords

Stem cell transplantationAirway hyper-reactivitymethacholinepediatric

Outcome Measures

Primary Outcomes (1)

  • Positive MCT after SCT may be associated with increased risk of pulmonary complications

    3 years followup

Secondary Outcomes (1)

  • The number of patients with airway reactivity increased after after SCT (p < 0.05; McNemar test).

    3 years followup

Eligibility Criteria

Age4 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children who underwent SCT in the Department of Pediatric Hemato-Oncology at Meyer Children's Hospital and were referred to the Pediatric Pulmonary Unit.

You may qualify if:

  • age 4.5-20 years
  • ability to perform spirometry consistently
  • FEV1\>70% predicted

You may not qualify if:

  • FEV1\<70%
  • inability to perform methacholine challenge test before and after stem cell transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Pulmonary Unit, Meyer Children's Hospital of Haifa, Meyer Children's Hospital, Rambam Medical Center, and the Bruce Rappaport Faculty of Medicine

Haifa, Israel

Location

Biospecimen

Retention: NONE RETAINED

Not retained

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Lea Bentur, MD

    Rambam Health Care Campus

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 27, 2008

First Posted

October 15, 2008

Study Start

July 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

October 15, 2008

Record last verified: 2008-10

Locations

IL(1)