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Pulmonary Function at Presentation and Follow-up in Hemato-Oncology 3-7 Years Old Children

This study has been completed.

Sponsored by: Sheba Medical Center
Information provided by: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00552825
  Purpose

The aim of this study was to investigate the occurrences of respiratory symptoms risk factors and abnormalities in lung function in young children (3-6 years old) with hemato-oncologic diseases at presentation (before treatment) and up to 3 years follow-up (study period).


Condition
Acute Lymphoblastic Leukemia
Acute Myeloblastic Leukemia
Solid Tumors,
Hodgkin's Disease
Non-Malignant

MedlinePlus related topics:   Cancer    Hodgkin's Disease    Leukemia, Childhood   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Retrospective
Official Title:   Pulmonary Function at Presentation and Follow-up in Hemato-Oncology 3-7 Years

Further study details as provided by Sheba Medical Center:

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment:   35
Study Start Date:   October 2005
Study Completion Date:   October 2006

Groups/Cohorts
1
all were in a single group

Detailed Description:

Pulmonary function tests (PFTs) are a part of the routine follow-up of patients receiving anti-cancer treatment. Treatment is frequently associated with diverse pulmonary damage which may become functionally and clinically evident many years later. PFTs may help to quantify the damage in the lungs; help to evaluate the point at which lung function deviates from normal to allow early intervention before irreversible lung damage occurs and thereby to reduce morbidity and mortality.

Reliable PFTs in the preschool age have traditionally been difficult to perform, but recent publications have demonstrated that the majority of preschool children can produce reproducible forced expiratory flow volume (FEVC) curves with proper coaching techniques. This recent development may enable studying the long term effect (years) of treatment on lung function in young children suffering from hemato-oncologic diseases.

  Eligibility
Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

All pediatric patients (age 3-7 years) with hemato-onclogic diseases that were treated at the Hemato-Oncology Department, and were sent to the pediatric pulmonary unit at the Safra children's hospital, Sheba medical center, Ramat-Gan, Israel, to perform lung function tests, as a part of a 3-year follow-up study.


Criteria

Inclusion Criteria:

  • All pediatric patients (age 3-7 years) with hemato-onclogic diseases that were treated at the Hemato-Oncology Department, and were sent to the pediatric pulmonary unit.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552825

Locations
Israel, Ramat Gan
Sheba Medical CenterPediatric pulmonary unit, Pulmonary function laboratory    
      Ramat-Gan, Ramat Gan, Israel, 52621

Sponsors and Collaborators
Sheba Medical Center

Investigators
Principal Investigator:     Ori Efrati, MD     Sheba Medical Center    
  More Information


Study ID Numbers:   SHEBA-05-3889-OE-CTIL, Observational
First Received:   November 1, 2007
Last Updated:   November 1, 2007
ClinicalTrials.gov Identifier:   NCT00552825
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
acute lymphoblastic leukemia  
long-term lung function  

Study placed in the following topic categories:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hodgkin's disease
Hodgkin lymphoma, adult
Acute myelogenous leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Lymphatic Diseases
Lymphoproliferative Disorders
Hodgkin Disease
Lymphoma
Acute myelocytic leukemia

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on October 07, 2008




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