RecruitingNot Applicable

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

Israel400 participantsStarted 2021-08-19

Plain-language 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).

Who can participate

Age range

6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: From allogeneic HSCT to 3 years after transplantation

Prevalence of small airway disease detected by FOT

Timeframe: From allogeneic HSCT to 3 years after transplantation

FOT measurements during follow-up and response to medical treatment

Timeframe: From allogeneic HSCT to 3 years after transplantation

Trial details

NCT IDNCT07730931

SponsorHadassah Medical Organization

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-30

Contact for this trial

Rottem Kuint, MD

+972532207609 KUINT@hadassah.org.il

View on ClinicalTrials.gov More Bronchiolitis Obliterable Syndrome trials

Plain-language summary

Who can participate

Age range

6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

What they're measuring

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

Timeframe: 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

Timeframe: From allogeneic HSCT to 3 years after transplantation

Prevalence of small airway disease detected by FOT

Timeframe: From allogeneic HSCT to 3 years after transplantation

FOT measurements during follow-up and response to medical treatment

Timeframe: From allogeneic HSCT to 3 years after transplantation