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Forced Oscillatory Technique for Bronchiolitis Obliterans Syndrome After Allogeneic Bone Marrow Transplantation

ConditionBronchiolitis Obliterable Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorHadassah Medical Organization

About this trial

Bronchiolitis obliterans syndrome (BOS) is a severe pulmonary complication following allogeneic hematopoietic stem cell transplantation (HSCT). This prospective study evaluates the usefulness of the Forced Oscillation Technique (FOT) for the diagnosis, early detection, monitoring, and assessment of treatment response in patients undergoing allogeneic HSCT. FOT results will be compared with standard pulmonary function tests (spirometry, lung volumes, and DLCO).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients age 6 months and above, undergoing allogeneic HSCT, referred for pulmonary function test evaluation at the Hadassah Ein Kerem Institute of Pulmonary Medicine .

Ability to provide informed consent for performing FOT and database enrollment by patient or legal guardians.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • FOT - Forced Oscillation Technique

    Diagnostic test

    Forced Oscillation Technique (FOT) performed in addition to standard pulmonary function testing for the assessment of bronchiolitis obliterans syndrome after allogeneic hematopoietic stem cell transplantation

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: FOT AssessmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic accuracy of FOT for early detection of Bronchiolitis obliterans syndrome (BOS)

Diagnostic accuracy of FOT for early detection of BOS, assessed by sensitivity, specificity, and comparison with standard pulmonary function tests.

Time frame
From allogeneic HSCT to 3 years after transplantation
2

Correlation between standard pulmonary function tests and Forced Oscillatory Technique (FOT) in patients with or without BOS following allo HSCT in children and adults

Correlation between standard pulmonary function tests parameters (spirometry, static lung volumes and DLCO) and Forced Oscillatory Technique (FOT) measurements in patients with or without BOS following allogeneic HSCT in children and adults

Time frame
From allogeneic HSCT to 3 years after transplantation
3

Prevalence of small airway disease detected by FOT

Prevalence of small airway disease detected by FOT following allogeneic HSCT, specifically in pediatric and adult patients with normal spirometry

Time frame
From allogeneic HSCT to 3 years after transplantation
4

FOT measurements during follow-up and response to medical treatment

4\. Changes in FOT measurements during follow up and response to medical treatment in these patients

Time frame
From allogeneic HSCT to 3 years after transplantation

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hadassah Medical Organization

Lead sponsor

Source ClinicalTrials.gov
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