Prospective Multicentre Cohort Study of Early Pulmonary Dysfunction in Childhood Cancer Patients (SWISS-Pearl Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary Dysfunction
- Sponsor
- University Children's Hospital Basel
- Enrollment
- 140
- Locations
- 5
- Primary Endpoint
- Change in total lung capacity (TLC)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in total lung capacity (TLC)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Secondary Outcomes
- Assessment of genetic variants through saliva or buccal cell sampling (collection of germline DNA)(At Baseline (start of therapy))
- 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)