Prospective Multicentre Cohort Study of Early Pulmonary Dysfunction in Childhood Cancer Patients (SWISS-Pearl Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 10
- 主要终点
- Change in total lung capacity (TLC)
研究概览
简要总结
This longitudinal, prospective, multicentre study is to monitor lung function prospectively in childhood cancer patients after diagnosis. The impact of cancer treatment on pulmonary dysfunction non-invasively using lung function, lung imaging and breath analysis as well as clinical symptoms using a questionnaire will be assessed at different time points.
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
- 4 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least one of the following cancer treatments:
- •chest radiation
- •treatment with any kind of chemotherapy
- •hematopoietic stem cell transplantation (HSCT)
- •thoracic surgery
- •consent for Childhood Cancer Registry (ChCR) registration
排除标准
- •no signed informed consent
- •Operation outside the chest area as only cancer treatment
- •Relapsed cancer (patients who develop relapse during the study will not be excluded)
- •In addition for MRI and lung function tests:
- •Subjects who are respiratory insufficient and cannot perform a lung function test (less than 92% O2 saturation; under O2 therapy)
- •MRI measurement not possible without sedation
- •Metal (e.g. pacemaker) in the body
结局指标
主要结局
Change in total lung capacity (TLC)
时间窗: At Baseline (start of therapy), at month 3 (during intensive treatment), at month 6-18 (end of intensive treatment), 12 months after end of intensive treatment,24 months after end of intensive treatment
Static lung function parameter: total lung capacity (TLC) to assess lung restriction
Change in Alveolar-capillary membrane diffusion
时间窗: At Baseline (start of therapy), at month 3 (during intensive treatment), at month 6-18 (end of intensive treatment), 12 months after end of intensive treatment,24 months after end of intensive treatment
Alveolar-capillary membrane diffusion
Change in residual volume (RV)/TLC
时间窗: At Baseline (start of therapy), at month 3 (during intensive treatment), at month 6-18 (end of intensive treatment), 12 months after end of intensive treatment,24 months after end of intensive treatment
Static lung function parameter: residual volume (RV)/TLC to assess hyperinflation
Change in ratio of FEV1/forced vital capacity (FVC) for airway obstruction
时间窗: At Baseline (start of therapy), at month 3 (during intensive treatment), at month 6-18 (end of intensive treatment), 12 months after end of intensive treatment,24 months after end of intensive treatment
Dynamic lung function parameter: ratio of FEV1/forced vital capacity (FVC) for airway obstruction
Change in Forced expiratory volume in 1 second (FEV1)
时间窗: At Baseline (start of therapy), at month 3 (during intensive treatment), at month 6-18 (end of intensive treatment), 12 months after end of intensive treatment,24 months after end of intensive treatment
Dynamic lung function parameter: Forced expiratory volume in 1 second (FEV1)
Change in lung clearance index (LCI)
时间窗: At Baseline (start of therapy), at month 3 (during intensive treatment), at month 6-18 (end of intensive treatment), 12 months after end of intensive treatment,24 months after end of intensive treatment
Global ventilation inhomogeneity assessed by lung clearance index (LCI)
Change in percentage portion of the lung volume with impaired ventilation or perfusion
时间窗: Before start of therapy, 12 months after end of intensive treatment,24 months after end of intensive treatment
Functional MRI: the primary outcome of functional lung imaging is the percentage portion of the lung volume with impaired ventilation or perfusion.
Change in lung morphology assessed by MRI
时间窗: Before start of therapy, 12 months after end of intensive treatment,24 months after end of intensive treatment
Change in lung morphology assessed by MRI (description of structural changes: ground glass changes, thickened septal lines, interstitial infiltrates, diffuse alveolar infiltrates, haemorrhage, focal consolidation, fibrosis, pulmonary hypertension, pleural effusion, nodular changes, vasculitis (wall thickening) and thrombosis will be assessed)
次要结局
- Change in 4-hydroxy-2-nonenal in exhaled breath(At Baseline (start of therapy), at month 3 (during intensive treatment), at month 6-18 (end of intensive treatment), 12 months after end of intensive treatment,24 months after end of intensive treatment)
- Change in volatile organic compounds (VOCs) in exhaled breath(At Baseline (start of therapy), at month 3 (during intensive treatment), at month 6-18 (end of intensive treatment), 12 months after end of intensive treatment,24 months after end of intensive treatment)
- Assessment of genetic variants through saliva or buccal cell sampling (collection of germline DNA)(At Baseline (start of therapy))