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RecruitingNCT07297303Updated Dec 22, 2025

Longitudinal Pulmonary Chronic Graft-versus-host-disease (GvHD) Assessment in Hematopoietic Stem Cell Transplantation (HSCT) Patients

An observational study in Bronchiolitis Obliterable Syndrome, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by National Taiwan University Hospital · Observational

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Bronchiolitis Obliterable Syndrome

Keywords

  • hematopoietic stem cell transplantation
  • GvHD
  • Obstructive airway disease
  • Pulmonary rehabilitation
  • Cardiopulmonary exercise test
03

In context

Lung Diseases, Obstructive

202 studies on the registry are indexed under Lung Diseases, Obstructive; 22 are open to participants now.

This study's planned enrollment of 600 is above the median of 185 across 48 observational studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

At National Taiwan University Hospital and National Taiwan University Hospital Cancer Center

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age>18
  2. Will Receive first time Allo- patients

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • A hematopoietic stem cell transplantation cohort
06

What researchers measure

Primary outcomes

  1. Prevalence of bronchiolitis obliterans syndrome

    Time frame: From enrollment to the end of treatment at 2 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — IPD will not be shared due to privacy concerns and limitations specified by the ethics committee/institutional review board.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07297303
Responsible party
Sponsor
First posted
Dec 22, 2025
Start date
Sep 30, 2025
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Dec 22, 2025

Study contacts

Ting-Yu Liao
Contact
tingyufish0129@gmail.com
+886 2312-3456
Zong-Han Yao
Contact
med92leoyau@gmail.com
+886 2312-3456

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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