Early Pulmonary Dysfunction in Childhood Cancer Patients

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест 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 (D
• Диагностический тест 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.
• Диагностический тест 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.
• Другое 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.
• Другое 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 surgica
• Другое 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.

Первичные конечные точки

• Change in Forced expiratory volume in 1 second (FEV1) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Before start of therapy, 12 months after end of intensive treatment,24 months after end of intensive treatment]

Вторичные конечные точки (3)

• Change in 4-hydroxy-2-nonenal in exhaled breath [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: At Baseline (start of therapy)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 5 центров

• University Children's Hospital Basel (UKBB) — Basel
• Universitätsklinik für Kinderheilkunde — Bern
• Geneva University Hospital — Geneva
• Centre hospitalier universitaire vaudois Lausanne — Lausanne
• Universitäts-Kinderspital Zürich — Zurich

Идентификаторы

NCT: NCT05427136 · 2021-01206; ks22Usemann

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗