Forced Oscillatory Technique for the Diagnosis, Monitoring, and Assessment of Treatment Response in Bronchiolitis Obliterans Syndrome Following Allogeneic Bone Marrow Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of FOT for early detection of Bronchiolitis obliterans syndrome (BOS)
研究概览
简要总结
Bronchiolitis obliterans syndrome (BOS) is a severe pulmonary complication following allogeneic hematopoietic stem cell transplantation (HSCT). This prospective study evaluates the usefulness of the Forced Oscillation Technique (FOT) for the diagnosis, early detection, monitoring, and assessment of treatment response in patients undergoing allogeneic HSCT. FOT results will be compared with standard pulmonary function tests (spirometry, lung volumes, and DLCO).
详细描述
This prospective study conducted at Hadassah Medical Organization. Patients aged 6 months and older undergoing allogeneic hematopoietic stem cell transplantation who are referred for pulmonary function testing will be enrolled. Participants will undergo standard pulmonary function tests according to routine clinical practice, including spirometry, static lung volumes, and DLCO, together with Forced Oscillation Technique (FOT). Clinical characteristics, transplant characteristics, pulmonary symptoms, graft-versus-host disease status, imaging findings, treatments, and pulmonary function parameters will be collected prospectively. Participants will be followed for up to three years to evaluate the role of FOT in the diagnosis, monitoring, and assessment of bronchiolitis obliterans syndrome and small airway disease following HSCT
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients age 6 months and above, undergoing allogeneic HSCT, referred for pulmonary function test evaluation at the Hadassah Ein Kerem Institute of Pulmonary Medicine .
- •Ability to provide informed consent for performing FOT and database enrollment by patient or legal guardians.
排除标准
- •1. Inability or unwillingness to perform FOT
结局指标
主要结局
Diagnostic accuracy of FOT for early detection of Bronchiolitis obliterans syndrome (BOS)
时间窗: From allogeneic HSCT to 3 years after transplantation
Diagnostic accuracy of FOT for early detection of BOS, assessed by sensitivity, specificity, and comparison with standard pulmonary function tests.
Correlation between standard pulmonary function tests and Forced Oscillatory Technique (FOT) in patients with or without BOS following allo HSCT in children and adults
时间窗: From allogeneic HSCT to 3 years after transplantation
Correlation between standard pulmonary function tests parameters (spirometry, static lung volumes and DLCO) and Forced Oscillatory Technique (FOT) measurements in patients with or without BOS following allogeneic HSCT in children and adults
Prevalence of small airway disease detected by FOT
时间窗: From allogeneic HSCT to 3 years after transplantation
Prevalence of small airway disease detected by FOT following allogeneic HSCT, specifically in pediatric and adult patients with normal spirometry
FOT measurements during follow-up and response to medical treatment
时间窗: From allogeneic HSCT to 3 years after transplantation
4\. Changes in FOT measurements during follow up and response to medical treatment in these patients
次要结局
未报告次要终点
研究者
Rotem Kuint
Principal Investigator Doctor KUINT ROTEM, Institute of Pulmonary Medicine
Hadassah Medical Organization