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

NCT07730931 | Recruiting

• 1 other identifier: 0401-21 HMO
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Bronchiolitis Obliterable Syndrome

Keywords

FOT; BOS; Bronchiolitis Obliterable Syndrome; Forced Oscillation Technique

Outcome Measures

Primary Outcomes (4)

• 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.

  From allogeneic HSCT to 3 years after transplantation

• 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

  From allogeneic HSCT to 3 years after transplantation

• 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

  From allogeneic HSCT to 3 years after transplantation

• 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

  From allogeneic HSCT to 3 years after transplantation

Study Arms (1)

FOT Assessment

EXPERIMENTAL

Diagnostic Test: FOT - Forced Oscillation Technique

Interventions

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

FOT Assessment

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Inability or unwillingness to perform FOT

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah MO, Jerusalem, 9574869, Jerusalem,

Jerusalem, Israel

RECRUITING

Central Study Contacts

Rottem Kuint, MD

CONTACT

+972532207609; KUINT@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Doctor KUINT ROTEM, Institute of Pulmonary Medicine

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 28, 2026
• Study Start: August 19, 2021
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2030
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

IL (1)