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