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

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ClinicalTrials.gov Identifier: NCT00552825
Recruitment Status : Completed
First Posted : November 2, 2007
Last Update Posted : November 2, 2007
Sponsor:
Information provided by:
Sheba Medical Center

Study Description
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Brief Summary:
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 or disease
Acute Lymphoblastic Leukemia Acute Myeloblastic Leukemia Solid Tumors, Hodgkin's Disease Non-Malignant

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.

Study Design
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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pulmonary Function at Presentation and Follow-up in Hemato-Oncology 3-7 Years
Study Start Date : October 2005
Actual Study Completion Date : October 2006

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Groups and Cohorts
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Group/Cohort
1
all were in a single group


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00552825


Locations
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Israel
Sheba Medical CenterPediatric pulmonary unit, Pulmonary function laboratory
Ramat-Gan, Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Ori Efrati, MD Sheba Medical Center
More Information
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ClinicalTrials.gov Identifier: NCT00552825    
Other Study ID Numbers: SHEBA-05-3889-OE-CTIL
Observational
First Posted: November 2, 2007    Key Record Dates
Last Update Posted: November 2, 2007
Last Verified: November 2007
Keywords provided by Sheba Medical Center:
acute lymphoblastic leukemia
long-term lung function
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Hodgkin Disease
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma