Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Neoplasms
- Design
- Observational Model: CohortTime Perspective: Other
Participation Requirements
- Age
- Younger than 22 years
- Gender
- Both males and females
Description
Specific objectives: To develop the infrastructure and instruments for setting-up a European, long-term registry of paediatric patients treated with modern external radiotherapy techniques ; To assess the incidence and severity of late health outcomes, primarily endocrine dysfunctions, cardiovascula...
Specific objectives: To develop the infrastructure and instruments for setting-up a European, long-term registry of paediatric patients treated with modern external radiotherapy techniques ; To assess the incidence and severity of late health outcomes, primarily endocrine dysfunctions, cardiovascular toxicities, neurovascular damages, and subsequent primary neoplasms, in relation to the dose-volume distribution to non-targeted organs and tissues, radiation delivery technique and beam quality factors, and potential modifying factors (i.e. age at exposure, genetic predispositions, comorbidities, and systemic treatments including chemotherapy, targeted therapy, immunotherapy and hormonal drugs) that may underlie differences in individual susceptibility for these outcomes ; To assess societal aspects of advances in radiotherapy, primarily health-related quality of life and academic achievement, in paediatric patients treated with modern external radiotherapy techniques. Secondary scientific objectives: To assess multidimensional fatigue in paediatric patients treated with modern external radiotherapy techniques, and identify clinical and therapeutic determinants of fatigue; To improve estimation of patient-specific doses to the whole body and non-targeted organs and substructures from different radiotherapy delivery techniques; To investigate radiation-induced cellular responses and biological mechanisms related to the occurrence of vascular diseases and subsequent primary neoplasms in samples of blood and saliva ; to identify biomarkers of susceptibility and health effects ; to evaluate differences in disease biomarkers in relation to the radiation delivery technique and beam quality factors ; to explore the relevance of the use of saliva as a biosampling method for paediatric cohorts regarding feasibility and the quality and reproducibility for different measured biomarkers. Secondary strategic objectives: To promote sustained collaborative research activities for improvement of patient care, and inform health care providers and policy makers on the clinical and social impact of advances in radiotherapy in paediatric settings; To serve as a pilot for a future long-term pan-European registry of children and adolescents treated with particle and photon beam therapy, including a biobank of saliva and blood samples collected before and after treatment; To contribute in future collaborative projects with existing cohorts or registries in Europe To contribute in future international research studies on late outcomes of modern radiotherapy techniques for management of paediatric cancers Funding: The HARMONIC project has received funding from the Euratom research and training programme 2014-2018 under grant agreement No 847707.
Tracking Information
- NCT #
- NCT04746729
- Collaborators
- Barcelona Institute for Global Health
- The West German Proton Therapy Centre, Essen
- Gustave Roussy, Cancer Campus, Grand Paris
- University Hospital, Essen
- Commissariat A L'energie Atomique
- Centre Francois Baclesse
- KU Leuven
- University of Aarhus
- Princess Maxima Center for Pediatric Oncology
- University Medical Center Groningen
- Stockholm University
- Aarhus University Hospital
- National Research Council, Institute of Clinical Physiology, Italy
- Luxembourg Institute of Science and Technology
- University of Zurich
- Investigators
- Study Director: Isabelle Thierry-chef, PhD Barcelona Institute for Global Health