Early Pulmonary Dysfunction in Childhood Cancer Patients (SWISS-Pearl)

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Dysfunction
• Intervention / Treatment: Diagnostic test: Lung function measurements; Diagnostic test: Breath Analysis; Diagnostic test: Magnetic resonance imaging (MRI); Other: Standardized interview to assess respiratory symptoms; Other: Data collection for assessment of clinical parameters and cumulative doses to chemotherapy, radiation, surgery and HSCT; Other: Collection of genetic samples

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: Jakob Usemann, PD Dr. med.; Phone Number: +41 61 704 12 12; Email: jakob.usemann@ukbb.ch
• Study Contact Backup: Name: Christine Schneider; Email: Christine.Schneider@insel.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4056
    • Recruiting
    • University Children's Hospital Basel (UKBB)
    • Contact: Jakob Usemann, PD Dr. med.; Phone Number: +41 61 704 12 12; Email: jakob.usemann@ukbb.ch
    • Principal Investigator: Jakob Usemann, PD Dr. med.
    • Sub-Investigator: Nicolas Von der Weid, Prof. Dr. med.
    • Sub-Investigator: Christina Schindera, Dr. med.
  • Bern, Switzerland, 3010
    • Recruiting
    • Universitätsklinik für Kinderheilkunde
    • Contact: Jochen Roessler, Prof. Dr. med.; Phone Number: +41 (0)31 632 94 95; Email: jochen.roessler@insel.ch
    • Contact: Christine Schneider, Dr. med.; Phone Number: +41 (0)31 632 21 11; Email: christine.schneider@insel.ch
    • Principal Investigator: Jochen Roessler, Prof. Dr. med.
    • Sub-Investigator: Philipp Latzin, Prof. Dr. med.
    • Sub-Investigator: Christine Schneider, Dr. med.
  • Geneva, Switzerland, 1211
    • Recruiting
    • Geneva University Hospital
    • Contact: Marc Ansari, Prof. Dr. med.; Email: marc.ansari@hcuge.ch
    • Principal Investigator: Marc Ansari, Prof. Dr. med.
  • Lausanne, Switzerland, 1011
    • Recruiting
    • Centre Hospitalier Universitaire Vaudois Lausanne
    • Contact: Manuel Diezi, Dr. med.
    • Principal Investigator: Manuel Diezi, Dr. med.
    • Sub-Investigator: Laura Crosazzo, Dr. med.
    • Sub-Investigator: Sylvain Blanchon, Dr. med.
  • Zurich, Switzerland, 8032
    • Recruiting
    • Universitäts-Kinderspital Zürich
    • Contact: Jean- Pierre Bourquin, Prof. Dr. med.
    • Principal Investigator: Jean- Pierre Bourquin, Prof. Dr. med.
    • Sub-Investigator: Alexander Moeller, Prof. Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 22 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Secondary Outcome Measures

Outcome Measure	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
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)

Collaborators and Investigators

• Sponsor: University Children's Hospital Basel
• Investigators: Principal Investigator: Jakob Usemann, PD Dr. med., University Children's Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): June 1, 2051
• Study Completion (Estimated): June 1, 2051

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Childhood cancer; Lung function; Lung imaging; Breath analysis; Exome-wide association studies (EWAS); Genome-wide association studies (GWAS); Pulmotoxic treatment
• Additional Relevant MeSH Terms: Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Diagnostic Techniques and Procedures; Diagnosis; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Physical Phenomena; Tomography; Diagnostic Imaging; Radiation; Magnetic Resonance Imaging; Surgical Procedures, Operative; Data Collection; Breath Tests
• Other Study ID Numbers: 2021-01206; ks22Usemann

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No