Long-term lung monitoring after allogeneic hematopoietic stem cell transplant for bronchiolitis obliterans syndrome
Longitudinal Pulmonary Chronic Graft-versus-host-disease (GvHD) Assessment in Hematopoietic Stem Cell Transplantation (HSCT) Patients
We will follow about 600 adults having their first allogeneic stem cell transplant to see how often and how bronchiolitis obliterans syndrome (pulmonary GvHD) appears and changes over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT07297303 on ClinicalTrials.gov |
What this trial studies
This prospective observational cohort will enroll roughly 600 adult Taiwanese recipients of first-time allogeneic hematopoietic stem cell transplantation and perform scheduled pulmonary function testing (including impulse oscillometry), imaging, cardiopulmonary exercise testing, and biomarker sampling to track pulmonary graft-versus-host disease (BOS). Participants will be followed serially after transplant to document timing of onset, symptom development, lung function decline, and radiographic changes and to relate these findings to clinical risk factors. The protocol excludes patients with prior lung transplant, active respiratory failure, hemodynamic instability, or inability to perform walking/exercise tests. Collected data aim to fill local gaps in epidemiology, improve understanding of early or subclinical disease, and inform follow-up and management strategies for HSCT recipients.
Who should consider this trial
Good fit: Adults over 18 scheduled for their first allogeneic HSCT at National Taiwan University Hospital who can ambulate at least 20 meters and cooperate with serial pulmonary testing are ideal candidates.
Not a fit: Patients with respiratory failure, need for continuous (all-day) oxygen, recent acute coronary syndrome, severe lower-limb arthropathy, inability to walk 20 meters, poor cooperation, or prior lung transplantation are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could identify earlier signs, risk factors, and biomarkers that help detect or monitor pulmonary GvHD sooner and guide follow-up care for transplant recipients.
How similar studies have performed: Prior cohort studies have described the timing, risk factors, and lung-function decline in BOS after HSCT, but effective treatments remain limited and local Taiwanese data have been sparse.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age\>18 2. Will Receive first time Allo-HSCT patients Exclusion Criteria: 1. Respiratory failure 2. Hemodynamic unstable 3. Pneumothorax or bronchial fistula 4. Acute coronary syndrome in recent 1 month 5. The patient couldn't walk longer than 20 m 6. Severe lower-limb arthropathy 7. The patient couldn't cooperate well 8. Need all-day oxygen supplement 9. The patient received lung transplantation before
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Ting-Yu Liao
- Email: tingyufish0129@gmail.com
- Phone: +886 2312-3456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.