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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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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.

Eligibility

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

Study details
    Bronchiolitis Obliterable Syndrome

NCT07297303

National Taiwan University Hospital

31 January 2026

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