Early Pulmonary Dysfunction in Childhood Cancer Patients
- Conditions
- Pulmonary Dysfunction
- Registration Number
- NCT05427136
- Lead Sponsor
- University Children's Hospital Basel
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 140
-
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
-
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)
- Pregnant
- MRI measurement not possible without sedation
- Metal (e.g. pacemaker) in the body
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in total lung capacity (TLC) 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 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 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 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) 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) 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 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 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 Outcome Measures
Name Time Method Assessment of genetic variants through saliva or buccal cell sampling (collection of germline DNA) At Baseline (start of therapy) Genetic variants associated with susceptibility to cancer therapy or related to lung development. Assessed in the Germline DNA Biobank Switzerland for childhood cancer and blood disorders (BISKIDS, as part of the Paediatric Biobank for Research in Haematology and Oncology \[BaHOP\], ethics approval PB_2017-00533 to assess genetic determinants of pulmonary toxicity.
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 Breath analysis: 4-hydroxy-2-nonenal is regarded as a surrogate marker for oxidative stress in the human body.
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 Untargeted explorative approach to assess volatile organic compounds (VOCs) in exhaled breath
Trial Locations
- Locations (5)
Universitäts-Kinderspital Zürich
🇨🇭Zürich, Switzerland
University Children's Hospital Basel (UKBB)
🇨🇭Basel, Switzerland
Centre hospitalier universitaire vaudois Lausanne
🇨🇭Lausanne, Switzerland
Universitätsklinik für Kinderheilkunde
🇨🇭Bern, Switzerland
Geneva University Hospital
🇨🇭Genève, Switzerland