Bronchiolitis Obliterable SyndromeNCT07297303
Longitudinal Pulmonary Chronic Graft-versus-host-disease (GvHD) Assessment in Hematopoietic Stem Cell Transplantation (HSCT) Patients
An observational study of Bronchiolitis Obliterable Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Prospective observational study on the clinical characteristics of pulmonary graft-versus-host disease in patients after hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiolitis Obliterable Syndrome
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Sep 2025to 31 Dec 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: At National Taiwan University Hospital and National Taiwan University Hospital Cancer Center
Who may be able to join
- Age>18
- Will Receive first time Allo-HSCT patients
Who cannot join
- Respiratory failure
- Hemodynamic unstable
- Pneumothorax or bronchial fistula
- Acute coronary syndrome in recent 1 month
- The patient couldn't walk longer than 20 m
- Severe lower-limb arthropathy
Show all 9Show fewer
- The patient couldn't cooperate well
- Need all-day oxygen supplement
- The patient received lung transplantation before
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
About this study
Prospective observational study on the clinical characteristics of pulmonary graft-versus-host disease in patients after hematopoietic stem cell transplantation.
Read the detailed description
In patients undergoing hematopoietic stem cell transplantation (HSCT), pulmonary complications include both infectious and non-infectious conditions. Among these, bronchiolitis obliterans syndrome(BOS) represents a severe manifestation of pulmonary graft-versus-host disease. BOS typically develops within two years after HSCT, with a median time to diagnosis ranging from 6 months to 1 year. However, it may occur at any time between 50 days and 10 years post-transplantation. During the early course of the disease, many patients are asymptomatic; progressive dyspnea and cough subsequently develop, usually over weeks to months. Potential risk factors include chronic graft-versus-host disease, older age, impaired pre-transplant pulmonary function, and early respiratory infections.
The current diagnostic criteria for BOS are still based on the recommendations of the 2014 National Institutes of Health Consensus on chronic graft-versus-host disease. Treatment for BOS remains complex and is supported by limited evidence. In Taiwan, local data on pulmonary complications-particularly BOS-remain insufficient.
We aim to establish a prospective cohort study enrolling approximately 600 participants to analyze the epidemiology, clinical manifestations, pulmonary function changes (including impulse oscillometry), imaging findings, and biomarker alterations associated with pulmonary graft-versus-host disease in Taiwanese HSCT recipients.
- Conditions
- Bronchiolitis Obliterable Syndrome
- Keywords
- hematopoietic stem cell transplantation, GvHD, Obstructive airway disease, Pulmonary rehabilitation, Cardiopulmonary exercise test
- Medical subject headings
- Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A hematopoietic stem cell transplantation cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of bronchiolitis obliterans syndrome
Measured: From enrollment to the end of treatment at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start30 Sep 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis Obliterable SyndromeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297303
- Sponsor's protocol ID
- 202501048RIND
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to privacy concerns and limitations specified by the ethics committee/institutional review board.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Pulmonary Chronic Graft-versus-host-disease (GvHD) Assessment in Hematopoietic Stem Cell Transplantation (HSCT) Patients
- ClinicalTrials.gov ID
- NCT07297303
- Acronym / sponsor ID
- 202501048RIND
- Conditions
- Bronchiolitis Obliterable Syndrome
- Keywords
- hematopoietic stem cell transplantation, GvHD, Obstructive airway disease, Pulmonary rehabilitation, Cardiopulmonary exercise test
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective observational study on the clinical characteristics of pulmonary graft-versus-host disease in patients after hematopoietic stem cell transplantation.
Detailed description
In patients undergoing hematopoietic stem cell transplantation (HSCT), pulmonary complications include both infectious and non-infectious conditions. Among these, bronchiolitis obliterans syndrome(BOS) represents a severe manifestation of pulmonary graft-versus-host disease. BOS typically develops within two years after HSCT, with a median time to diagnosis ranging from 6 months to 1 year. However, it may occur at any time between 50 days and 10 years post-transplantation. During the early course of the disease, many patients are asymptomatic; progressive dyspnea and cough subsequently develop, usually over weeks to months. Potential risk factors include chronic graft-versus-host disease, older age, impaired pre-transplant pulmonary function, and early respiratory infections.
The current diagnostic criteria for BOS are still based on the recommendations of the 2014 National Institutes of Health Consensus on chronic graft-versus-host disease. Treatment for BOS remains complex and is supported by limited evidence. In Taiwan, local data on pulmonary complications-particularly BOS-remain insufficient.
We aim to establish a prospective cohort study enrolling approximately 600 participants to analyze the epidemiology, clinical manifestations, pulmonary function changes (including impulse oscillometry), imaging findings, and biomarker alterations associated with pulmonary graft-versus-host disease in Taiwanese HSCT recipients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A hematopoietic stem cell transplantation cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- At National Taiwan University Hospital and National Taiwan University Hospital Cancer Center
Key inclusion criteria (2 listed)
- Age>18
- Will Receive first time Allo-HSCT patients
Key exclusion criteria (9 listed)
- Respiratory failure
- Hemodynamic unstable
- Pneumothorax or bronchial fistula
- Acute coronary syndrome in recent 1 month
- The patient couldn't walk longer than 20 m
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of bronchiolitis obliterans syndrome
Time frame: From enrollment to the end of treatment at 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No. IPD will not be shared due to privacy concerns and limitations specified by the ethics committee/institutional review board.
Related trials for Bronchiolitis Obliterable Syndrome
Recruiting
Forced Oscillatory Technique for Bronchiolitis Obliterans Syndrome After Allogeneic Bone Marrow Transplantation
Bronchiolitis Obliterable Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis Obliterable Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting-Yu Liao (+886 2312-3456, tingyufish0129@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of bronchiolitis obliterans syndrome (time frame: From enrollment to the end of treatment at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.