Early Pulmonary Dysfunction in Childhood Cancer Patients
NCT ID: NCT05427136
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
140 participants
OBSERVATIONAL
2021-06-01
2051-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* chest radiation
* treatment with any kind of chemotherapy
* hematopoietic stem cell transplantation (HSCT)
* thoracic surgery
* consent for Childhood Cancer Registry (ChCR) registration
Exclusion Criteria
* 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
4 Years
22 Years
ALL
No
Sponsors
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University Children's Hospital Basel
OTHER
Responsible Party
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Principal Investigators
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Jakob Usemann, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University Children's Hospital Basel, UKBB
Locations
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University Children's Hospital Basel (UKBB)
Basel, , Switzerland
Universitätsklinik für Kinderheilkunde
Bern, , Switzerland
Geneva University Hospital
Geneva, , Switzerland
Centre hospitalier universitaire vaudois Lausanne
Lausanne, , Switzerland
Universitäts-Kinderspital Zürich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Manuel Diezi, Dr. med.
Role: primary
Jean- Pierre Bourquin, Prof. Dr. med.
Role: primary
Other Identifiers
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2021-01206; ks22Usemann
Identifier Type: -
Identifier Source: org_study_id
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