Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Anti-Bacterial Agents

Bleomycin

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Methotrexate

Melphalan

Lomustine

Ifosfamide

Antibiotics, Antitubercular

Busulfan

Thiotepa

Carmustine

Carbon Monoxide

Isophosphamide mustard

All lung function tests are non-invasive and last about 60 minutes per child:

* Multiple Breath Washout: The nitrogen multiple-breath-washout test (N2MBW) measures ventilation inhomogeneity of the lung that occurs when smaller airways are damaged.
* Spirometry/Bodyplethysmography/DLCO: Spirometry measures dynamic air flows to quantify airway obstruction of large airways and pulmonary restriction. Plethysmography assesses static lung volumes. Diffusing capacity of the lung for carbon monoxide (DLCO) evaluates diffusion deficits.

Lung function measurements

Patients will exhale into a secondary electrospray-ionization-mass spectrometry (SESI-MS) breath analysis platform. SESI-MS allows real-time breath-printing by detection of both volatile and non-volatile trace components.

Breath Analysis

Functional MRI scan assessing regional fractional lung ventilation and relative perfusion, followed by a morphological MRI scan. This technique allows simultaneous assessment of all affected lung components, the airways, alveoli and pulmonary vasculature.

Magnetic resonance imaging (MRI)

Short questions on current airway symptoms, recent colds, exercise-related respiratory symptoms, and passive smoking exposure will be assessed. The interview takes about 10 minutes.

Standardized interview to assess respiratory symptoms

Assessment of clinical parameters and cumulative doses to chemotherapy, radiation, surgery and hematopoietic stem cell transplantation (HSCT). Data on cumulative doses of pulmotoxic chemotherapy (carmustine, lomustine, busulfan, bleomycin, methotrexate and cyclophosphamide, fludarabine, ifosfamide, melphalan and thiotepa) and radiation therapy at the region of the chest from patient's hospital charts will be collected. Information on chest wall and lung surgery will be retrieved from the surgical reports. Information about conditioning regimens including cumulative chemotherapy doses and total body irradiation of patients undergoing HSCT will be collected. Further information on the health state of the patient and interventions (e.g. development of pneumonia, antibiotic treatment) will be collected from the hospital charts.

Data collection for assessment of clinical parameters and cumulative doses to chemotherapy, radiation, surgery and HSCT

Germline DNA is collected (e.g. through saliva or buccal cell sampling) for later analysis on genetic risk factors for pulmonary complications.

Collection of genetic samples

Jakob Usemann, PD Dr. med.

Christine Schneider

Nicolas Von der Weid, Prof. Dr. med.

Christina Schindera, Dr. med.

Jochen Roessler, Prof. Dr. med.

Christine Schneider, Dr. med.

Philipp Latzin, Prof. Dr. med.

Marc Ansari, Prof. Dr. med.

Manuel Diezi, Dr. med.

Laura Crosazzo, Dr. med.

Sylvain Blanchon, Dr. med.

Jean- Pierre Bourquin, Prof. Dr. med.

Alexander Moeller, Prof. Dr. med.

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.

For study participants who signed further the general consent form, biological materials and health-related data will be coded and stored in a secure biobank/database (BaHOP). The biological material and genetic data are kept in the BaHOP biobank for an indefinite period of time for further, until now not defined research questions.

Early Pulmonary Dysfunction in Childhood Cancer Patients

Prospective Multicentre Cohort Study of Early Pulmonary Dysfunction in Childhood Cancer Patients (SWISS-Pearl Study)

Dynamic lung function parameter: Forced expiratory volume in 1 second (FEV1)

Dynamic lung function parameter: ratio of FEV1/forced vital capacity (FVC) for airway obstruction

Static lung function parameter: total lung capacity (TLC) to assess lung restriction

Static lung function parameter: residual volume (RV)/TLC to assess hyperinflation

Global ventilation inhomogeneity assessed by lung clearance index (LCI)

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 (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)

Breath analysis: 4-hydroxy-2-nonenal is regarded as a surrogate marker for oxidative stress in the human body.

Untargeted explorative approach to assess volatile organic compounds (VOCs) in exhaled breath

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Early Pulmonary Dysfunction in Childhood Cancer Patients	NCT05427136	Pulmonary Dysfu...	Lung function m... Breath Analysis Magnetic resona... Standardized in... Data collection... Collection of g...	4 Years - 22 Years	University Children's Hospital Basel
Early Pulmonary Dysfunction in Childhood Cancer Patients	NCT05427136	Pulmonary Dysfu...	Lung function m... Breath Analysis Magnetic resona... Standardized in... Data collection... Collection of g...	4 Years - 22 Years	University Children's Hospital Basel

Spots Global Cancer Trial Database for collection of genetic samples