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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07297303
Enrollment
600
Registered
2025-12-22
Start date
2025-09-30
Completion date
2030-12-31
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis Obliterable Syndrome

Keywords

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

Brief summary

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.

Interventions

None listed

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Prevalence of bronchiolitis obliterans syndromeFrom enrollment to the end of treatment at 2 years

Countries

Taiwan

Contacts

Primary ContactTing-Yu Liao
tingyufish0129@gmail.com+886 2312-3456
Backup ContactZong-Han Yao
med92leoyau@gmail.com+886 2312-3456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026