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

NCT ID: NCT00552825

Last Updated: 2007-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-10-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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

Keywords

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acute lymphoblastic leukemia long-term lung function

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

all were in a single group

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Ori Efrati, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba Medical CenterPediatric pulmonary unit, Pulmonary function laboratory

Ramat Gan, Ramat Gan, Israel

Site Status

Countries

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Israel

Other Identifiers

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Observational

Identifier Type: -

Identifier Source: secondary_id

SHEBA-05-3889-OE-CTIL

Identifier Type: -

Identifier Source: org_study_id