Clinical trial NCT05427136: Early Pulmonary Dysfunction in Childhood Cancer Patients
Official title: Prospective Multicentre Cohort Study of Early Pulmonary Dysfunction in Childhood Cancer Patients (SWISS-Pearl Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Dysfunction
Keywords: Childhood cancer
Lung function
Lung imaging
Breath analysis
Exome-wide association studies (EWAS)
Genome-wide association studies (GWAS)
Pulmotoxic treatment
Lead sponsor: University Children's Hospital Basel
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 140
Sex: ALL
Minimum age (years): 4
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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 be assessed at different time points.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Forced expiratory volume in 1 second (FEV1)
timeFrame: 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: Change in ratio of FEV1/forced vital capacity (FVC) for airway obstruction
timeFrame: 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: Change in total lung capacity (TLC)
timeFrame: 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: Change in residual volume (RV)/TLC
timeFrame: 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: Change in lung clearance index (LCI)
timeFrame: 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: Change in Alveolar-capillary membrane diffusion
timeFrame: 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: Change in percentage portion of the lung volume with impaired ventilation or perfusion
timeFrame: Before start of therapy, 12 months after end of intensive treatment,24 months after end of intensive treatment
measure: Change in lung morphology assessed by MRI
timeFrame: Before start of therapy, 12 months after end of intensive treatment,24 months after end of intensive treatment
Secondary outcomes:
measure: Change in 4-hydroxy-2-nonenal in exhaled breath
timeFrame: 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: Change in volatile organic compounds (VOCs) in exhaled breath
timeFrame: 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: Assessment of genetic variants through saliva or buccal cell sampling (collection of germline DNA)
timeFrame: At Baseline (start of therapy)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Children's Hospital Basel (UKBB)
city: Bern
country: Switzerland
facility: Universitätsklinik für Kinderheilkunde
city: Genève
country: Switzerland
facility: Geneva University Hospital
city: Lausanne
country: Switzerland
facility: Centre hospitalier universitaire vaudois Lausanne
city: Zürich
country: Switzerland
facility: Universitäts-Kinderspital Zürich
Study officials:
affiliation: University Children's Hospital Basel, UKBB
name: Jakob Usemann, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: