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NCT Number: NCT05427136

Early Pulmonary Dysfunction in Childhood Cancer Patients

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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Key information

Conditions

Pulmonary Dysfunction Neoplasms

Age range

4 year–22 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Basel (UKBB), Basel, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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:
  • 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

Treatment and study plan

lung function measurements

Diagnostic 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 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

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.

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Schneider

CONTACT

[email protected]

Jakob Usemann, PD Dr. med.

CONTACT

[email protected]

+41 61 704 12 12

Sponsors and collaborators

Lead sponsor

University Children's Hospital Basel

Other

Registry information

Official study title

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

Acronym: SWISS-Pearl

Important dates

Study start
2021
Primary completion
2051
Study completion
2051
First posted
Jun 22, 2022
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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