跳至主要内容
临床试验/NCT07297303
NCT07297303招募中不适用

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

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年9月30日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
1
主要终点
Prevalence of bronchiolitis obliterans syndrome

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Will Receive first time Allo-HSCT patients

排除标准

  • 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

结局指标

主要结局

Prevalence of bronchiolitis obliterans syndrome

时间窗: From enrollment to the end of treatment at 2 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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