Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy
NCT ID: NCT04746729
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2670 participants
OBSERVATIONAL
2021-01-11
2040-09-30
Brief Summary
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Detailed Description
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* To develop the infrastructure and instruments for setting-up a European, long-term registry of paediatric patients treated with contemporary techniques of modern external radiotherapy;
* 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.
Conditions
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Study Design
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COHORT
OTHER
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* Age under 22 years at the time of first EBRT initiation
* Radiation treatment plan (first EBRT) stored in DICOM format
* Usual residency in the country of EBRT to enable a long-term follow-up
* Scheduled first EBRT for management of a first primary neoplasm
* Age under 22 years at the time of scheduled first EBRT
* Radiation treatment plan stored in DICOM format
* Affiliate or beneficiary of health insurance (or any required equivalent as defined in applicable national law)
* Usual residency in the country of EBRT to enable a long-term follow-up
* Signed informed consent/assent
Exclusion Criteria
* Prior external or internal radiation therapy
* Patients who refused to participate in the study
Prospective inclusion of study participants
* Patients with poor prognosis (e.g. diffuse pontine glioma or high grade glioma)
* Prior external or internal radiation therapy;
* Protected adults (persons under curatorship, tutorship / individuals under guardianship by court order, persons deprived of their liberty)
* Adult/parent(s)/legal representative(s) who cannot read or understand the informed consent in the applicable language(s) in the country of EBRT
22 Years
ALL
No
Sponsors
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Barcelona Institute for Global Health
OTHER
The West German Proton Therapy Centre, Essen
UNKNOWN
Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Centre Francois Baclesse
OTHER
KU Leuven
OTHER
University of Aarhus
OTHER
Princess Maxima Center for Pediatric Oncology
OTHER
University Medical Center Groningen
OTHER
Stockholm University
OTHER
National Research Council, Institute of Clinical Physiology, Italy
OTHER
University of Zurich
OTHER
Commissariat A L'energie Atomique
OTHER_GOV
Luxembourg Institute of Science and Technology
OTHER
University Hospital, Essen
OTHER
Aarhus University Hospital
OTHER
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Responsible Party
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Principal Investigators
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Beate Timmermann, MD
Role: PRINCIPAL_INVESTIGATOR
UK Essen
Neige Journy, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut National de la Santé Et de la Recherche Médicale, France
Stéphanie Bolle, MD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Isabelle Thierry-chef, PhD
Role: STUDY_CHAIR
Barcelona Institute for Global Health
Locations
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KU Leuven
Leuven, , Belgium
Aarhus University hospital
Aarhus, , Denmark
Centre Régional François Baclesse
Caen, , France
Gustave Roussy
Villejuif, , France
University Hospital Essen, The West German Proton Therapy Centre Essen
Essen, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Journy N, Bolle S, Brualla L, Dumas A, Fresneau B, Haddy N, Haghdoost S, Haustermans K, Jackson A, Karabegovic S, Lassen-Ramshad Y, Thariat J, Wette MR, Botzenhardt S, De Wit I, Demoor-Goldschmidt C, Christiaens M, Hoyer M, Isebaert S, Jacobs S, Henriksen LT, Maduro JH, Ronckers C, Steinmeier T, Uyttebroeck A, Van Beek K, Walsh L, Thierry-Chef I, Timmermann B. Assessing late outcomes of advances in radiotherapy for paediatric cancers: Study protocol of the "HARMONIC-RT" European registry (NCT 04746729). Radiother Oncol. 2024 Jan;190:109972. doi: 10.1016/j.radonc.2023.109972. Epub 2023 Nov 2. No abstract available.
Related Links
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Project's website
Other Identifiers
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2020-A01037-32/1
Identifier Type: REGISTRY
Identifier Source: secondary_id
C20-01
Identifier Type: -
Identifier Source: org_study_id
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