Pulmonary DysfunctionSWISS-PearlNCT05427136
Early Pulmonary Dysfunction in Childhood Cancer Patients
An observational study of Pulmonary Dysfunction, run by University Children's Hospital Basel at 5 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 22 years
- Conditions the study is for
- Pulmonary Dysfunction
- What is being tested?
- Lung function measurements, Breath Analysis and Magnetic resonance imaging (MRI)
- How many people
- 140 participants
- Where
- 5 sitesSwitzerland
- Study dates
- 1 Jun 2021to Jun 2051
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Christine Schneider contact
5 sites in 1 country
Switzerland5 sites, 5 recruiting
- Recruiting
University Children's Hospital Basel (UKBB)
Basel, 4056
Jakob Usemann, PD Dr. med., +41 61 704 12 12, jakob.usemann@ukbb.ch
Jakob Usemann, PD Dr. med.
- Recruiting
Universitätsklinik für Kinderheilkunde
Bern, 3010
Jochen Roessler, Prof. Dr. med., +41 (0)31 632 94 95, jochen.roessler@insel.ch
Christine Schneider, Dr. med., +41 (0)31 632 21 11, christine.schneider@insel.ch
- Recruiting
Geneva University Hospital
Geneva, 1211
Marc Ansari, Prof. Dr. med., marc.ansari@hcuge.ch
Marc Ansari, Prof. Dr. med.
- Recruiting
Centre hospitalier universitaire vaudois Lausanne
Lausanne, 1011
Manuel Diezi, Dr. med.
Manuel Diezi, Dr. med.
- Recruiting
Universitäts-Kinderspital Zürich
Zurich, 8032
Jean- Pierre Bourquin, Prof. Dr. med.
Jean- Pierre Bourquin, Prof. Dr. med.
About this study
Official title: Prospective Multicentre Cohort Study of Early Pulmonary Dysfunction in Childhood Cancer Patients (SWISS-Pearl Study)
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.
- Conditions
- Pulmonary Dysfunction
- Being tested
- Lung function measurements, Breath Analysis, Magnetic resonance imaging (MRI), Standardized interview to assess respiratory symptoms, Data collection for assessment of clinical parameters and cumulative doses to chemotherapy, radiation, surgery and HSCT
- Keywords
- Childhood cancer, Lung function, Lung imaging, Breath analysis, Exome-wide association studies (EWAS), Genome-wide association studies (GWAS), Pulmotoxic treatment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung function measurementsDiagnostic test
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 AnalysisDiagnostic 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 symptomsOther
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 HSCTOther
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 samplesOther
Germline DNA is collected (e.g. through saliva or buccal cell sampling) for later analysis on genetic risk factors for pulmonary complications.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced expiratory volume in 1 second (FEV1)
Dynamic lung function parameter: Forced expiratory volume in 1 second (FEV1)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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 Alveolar-capillary membrane diffusion
Alveolar-capillary membrane diffusion
Measured: 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.
Measured: 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)
Measured: Before start of therapy, 12 months after end of intensive treatment,24 months after end of intensive treatment
Secondary outcomes (3)
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.
Measured: 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 volatile organic compounds (VOCs) in exhaled breath
Untargeted explorative approach to assess volatile organic compounds (VOCs) in exhaled breath
Measured: 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.
Measured: At Baseline (start of therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Jun 2021
- Primary completionJun 2051 (estimated)
- Study completionJun 2051 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakob Usemann, PD Dr. med., Principal investigator, University Children's Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427136
- Sponsor's protocol ID
- 2021-01206; ks22Usemann
- Acronym
- SWISS-Pearl
- Status last verified
- May 2026
- First submitted
- 1 Jun 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentre Cohort Study of Early Pulmonary Dysfunction in Childhood Cancer Patients (SWISS-Pearl Study)
- ClinicalTrials.gov ID
- NCT05427136
- Acronym / sponsor ID
- SWISS-Pearl / 2021-01206; ks22Usemann
- Conditions
- Pulmonary Dysfunction
- Keywords
- Childhood cancer, Lung function, Lung imaging, Breath analysis, Exome-wide association studies (EWAS), Genome-wide association studies (GWAS), Pulmotoxic treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Children's Hospital BaselUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Jun 2051 (estimated)
- Study completion
- Jun 2051 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- at least one of the following cancer treatments:
- consent for Childhood Cancer Registry (ChCR) registration
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung function measurementsAll 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. | Diagnostic test | – |
| Breath AnalysisPatients 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. | Diagnostic test | – |
| 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. | Diagnostic test | – |
| Standardized interview to assess respiratory symptomsShort questions on current airway symptoms, recent colds, exercise-related respiratory symptoms, and passive smoking exposure will be assessed. The interview takes about 10 minutes. | Other | – |
| Data collection for assessment of clinical parameters and cumulative doses to chemotherapy, radiation, surgery and HSCTAssessment 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. | Other | – |
| Collection of genetic samplesGermline DNA is collected (e.g. through saliva or buccal cell sampling) for later analysis on genetic risk factors for pulmonary complications. | Other | – |
Primary outcome
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)
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
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
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
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)
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
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.
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)
3 secondary outcomes
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
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
Assessment of genetic variants through saliva or buccal cell sampling (collection of germline DNA)
Time frame: At Baseline (start of therapy)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Schneider contact
Jakob Usemann, PD Dr. med. principal investigator
University Children's Hospital Basel
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Dysfunction, run by University Children's Hospital Basel at 5 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakob Usemann, PD Dr. med. (+41 61 704 12 12, jakob.usemann@ukbb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.