HARMONIC Project - Health effects of cArdiac fluoRoscopy and MOderN radIotherapy in paediatriCs

Part of EU Open Research Repository
Published September 24, 2020 | Version v1
Journal article Open

The HARMONIC project: study design for the assessment of radiation doses and associated cancer risks following cardiac fluoroscopy in childhood

Authors/Creators

  • 1. Barcelona Institute for Global Health, (ISGlobal), Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Publica (CIBERESP), Madrid, Spain; Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, United Kingdom
  • 2. Barcelona Institute for Global Health, (ISGlobal), Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Publica (CIBERESP), Madrid, Spain
  • 3. Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, United Kingdom
  • 4. Institut de Radioprotection et de Surete Nucleaire (IRSN), Fontenay-aux-Roses, France
  • 5. Istituto di Fisiologia Clinica del CNR, Pisa, Italy
  • 6. Leibniz Institute for Prevention Research and Epidemiology (BIPS), Bremen, Germany
  • 7. Leibniz Institute for Prevention Research and Epidemiology (BIPS), Bremen, Germany; Health Sciences Bremen, University of Bremen, Bremen, Germany
  • 8. Faculty of Health and Social Sciences, University of South-Eastern Norway, Kongsberg, Norway
  • 9. Cancer Registry of Norway—Institute of Population-based Cancer Research, Department of Research, Oslo, Norway
  • 10. Department of Pediatric Cardiology, Oslo University Hospital, Norway
  • 11. Luxembourg Institute of Science and Technology (LIST), Esch-sur-Alzette, Luxembourg
  • 12. National Research Center for Radiation Medicine (NRCRM), Kyiv, Ukraine
  • 13. Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, 9609 Medical Center Dr, Bethesda, MD 20892-9778, United States of America
  • 14. Belgian Nuclear Research Centre, SCK CEN, Mol, Belgium

Description

The HARMONIC project (Health Effects of Cardiac Fluoroscopy and Modern Radiotherapy in Paediatrics) is a European study aiming to improve our understanding of the long-term health risks from radiation exposures in childhood and early adulthood. Here, we present the study design for the cardiac fluoroscopy component of HARMONIC. A pooled cohort of approximately 100 000 patients who underwent cardiac fluoroscopy procedures in Belgium, France, Germany, Italy, Norway, Spain or the UK, while aged under 22 years, will be established from hospital records and/or insurance claims data. Doses to individual organs will be estimated from dose indicators recorded at the time of examination, using a lookup-table-based dosimetry system produced using Monte Carlo radiation transport simulations and anatomically realistic computational phantom models. Information on beam geometry and x-ray energy spectra will be obtained from a representative sample of radiation dose structured reports. Uncertainties in dose estimates will be modelled using 2D Monte Carlo methods. The cohort will be followed up using national registries and insurance records to determine vital status and cancer incidence. Information on organ transplantation (a major risk factor for cancer development in this patient group) and/or other conditions predisposing to cancer will be obtained from national or local registries and health insurance data, depending on country. The relationship between estimated radiation dose and cancer risk will be investigated using regression modelling. Results will improve information for patients and parents and aid clinicians in managing and implementing changes to reduce radiation risks without compromising medical benefits.

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Additional details

Funding

European Commission
HARMONIC - Health effects of cArdiac fluoRoscopy and MOderN radIotherapy in paediatriCs 847707