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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung function measurements | Diagnostic Test | All lung function tests are non-invasive and last about 60 minutes per child:
| ||
| Breath Analysis | Diagnostic Test | 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) | Diagnostic Test | 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 | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Forced expiratory volume in 1 second (FEV1) | Dynamic lung function parameter: 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 |
| Change in ratio of FEV1/forced vital capacity (FVC) for airway obstruction | Dynamic lung function parameter: 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 |
| Change in total lung capacity (TLC) | Static lung function parameter: total lung capacity (TLC) to assess lung restriction | 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 residual volume (RV)/TLC | Static lung function parameter: residual volume (RV)/TLC to assess hyperinflation | 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 lung clearance index (LCI) | Global ventilation inhomogeneity assessed by 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 4-hydroxy-2-nonenal in exhaled breath | Breath analysis: 4-hydroxy-2-nonenal is regarded as a surrogate marker for oxidative stress in the human body. | 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 |
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Inclusion Criteria:
at least one of the following cancer treatments:
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:
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Every new diagnosed cancer patient and every cancer patient planned for HSCT who is 4 years or older will be asked by the paediatric oncologist to participate in the study. This study will be conducted at the University Children's Hospital of Basel, Bern, Geneva, Lausanne and Zürich.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jakob Usemann, PD Dr. med. | Contact | +41 61 704 12 12 | jakob.usemann@ukbb.ch | |
| Christine Schneider | Contact | Christine.Schneider@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Jakob Usemann, PD Dr. med. | University Children's Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Children's Hospital Basel (UKBB) | Recruiting | Basel | 4056 | Switzerland |
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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.
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 | Other | 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 | Other | Germline DNA is collected (e.g. through saliva or buccal cell sampling) for later analysis on genetic risk factors for pulmonary complications. |
| Change in Alveolar-capillary membrane diffusion | 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 |
| Change in percentage portion of the lung volume with impaired ventilation or perfusion | Functional MRI: the primary outcome of functional lung imaging is the 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 |
| Change in lung morphology assessed by MRI | 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) | Before start of therapy, 12 months after end of intensive treatment,24 months after end of intensive treatment |
| Change in volatile organic compounds (VOCs) in exhaled breath | Untargeted explorative approach to assess 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) | 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. | At Baseline (start of therapy) |
| Universitätsklinik für Kinderheilkunde | Recruiting | Bern | 3010 | Switzerland |
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| Geneva University Hospital | Recruiting | Geneva | 1211 | Switzerland |
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| Centre hospitalier universitaire vaudois Lausanne | Recruiting | Lausanne | 1011 | Switzerland |
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| Universitäts-Kinderspital Zürich | Recruiting | Zurich | 8032 | Switzerland |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001944 | Breath Tests |
| D008279 | Magnetic Resonance Imaging |
| D003625 | Data Collection |
| D011827 | Radiation |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D055585 | Physical Phenomena |
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