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NCT Number: NCT07297303

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

Prospective observational study on the clinical characteristics of pulmonary graft-versus-host disease in patients after hematopoietic stem cell transplantation.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age>18
  • Will Receive first time Allo-HSCT patients

Exclusion criteria

  • 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
  • The patient couldn't cooperate well
  • Need all-day oxygen supplement
  • The patient received lung transplantation before

Treatment and study plan

Primary outcomes

  1. Prevalence of bronchiolitis obliterans syndrome

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ting-Yu Liao

CONTACT

[email protected]

+886 2312-3456

Zong-Han Yao

CONTACT

[email protected]

+886 2312-3456

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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