University Children's Hospital Basel (UKBB) 4056 Basel SwitzerlandRekrutierend» Google-Maps Ansprechpartner: Jakob Usemann, PD Dr. med. Phone: +41 61 704 12 12 E-Mail: jakob.usemann@ukbb.ch» Ansprechpartner anzeigenUniversitätsklinik für Kinderheilkunde 3010 Bern SwitzerlandRekrutierend» Google-Maps Ansprechpartner: Jochen Roessler, Prof. Dr. med. Phone: +41 (0)31 632 94 95 E-Mail: jochen.roessler@insel.ch
Christine Schneider, Dr. med. Phone: +41 (0)31 632 21 11 E-Mail: christine.schneider@insel.ch» Ansprechpartner anzeigenGeneva University Hospital 1211 Genève SwitzerlandRekrutierend» Google-Maps Ansprechpartner: Marc Ansari, Prof. Dr. med. E-Mail: marc.ansari@hcuge.ch» Ansprechpartner anzeigen
Centre hospitalier universitaire vaudois Lausanne 1011 Lausanne SwitzerlandRekrutierend» Google-Maps Ansprechpartner: Manuel Diezi, Dr. med.» Ansprechpartner anzeigenUniversitäts-Kinderspital Zürich 8032 Zürich SwitzerlandRekrutierend» Google-Maps Ansprechpartner: Jean- Pierre Bourquin, Prof. Dr. med.» Ansprechpartner anzeigen
1. 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)
2. 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
3. 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
4. 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
5. 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)
6. 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
7. 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.
8. 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 outcome:
1. Change in 4-hydroxy-2-nonenal in exhaled breath (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): Breath analysis: 4-hydroxy-2-nonenal is regarded as a surrogate marker for oxidative stress in the human body.
2. Change in volatile organic compounds (VOCs) in exhaled breath (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): Untargeted explorative approach to assess volatile organic compounds (VOCs) in exhaled breath
3. Assessment of genetic variants through saliva or buccal cell sampling (collection of germline DNA) (Time Frame - 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.
Lung function measurements: 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.
Breath Analysis: 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.
Magnetic resonance imaging (MRI): 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.
Standardized interview to assess respiratory symptoms: 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.
Data collection for assessment of clinical parameters and cumulative doses to chemotherapy, radiation, surgery and HSCT: 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.
Collection of genetic samples: Germline DNA is collected (e.g. through saliva or buccal cell sampling) for later analysis on genetic risk factors for pulmonary complications.
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"Early Pulmonary Dysfunction in Childhood Cancer Patients"
Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.
Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!
