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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552825
• Other study ID #: SHEBA-05-3889-OE-CTIL
• Secondary ID: Observational
• Status: Completed
• Phase: N/A
• First received: November 1, 2007
• Last updated: November 1, 2007
• Start date: October 2005
• Est. completion date: October 2006

Study information

• Verified date: November 2007
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 7 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloblastic Leukemia
• Hodgkin Disease
• Hodgkin's Disease
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Non-Malignant
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Solid Tumors,

Locations

Country	Name	City	State
Israel	Sheba Medical CenterPediatric pulmonary unit, Pulmonary function laboratory	Ramat-Gan	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel,