Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: No intervention.
- Кому может быть актуально
- Состояния в реестре: Neoplasms. Базовые параметры: до 22 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Бельгия, Дания, Франция, Германия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy (HARMONIC-RT)
Обзор
The goal of the HARMONIC-RT study is to evaluate late health and social outcomes of contemporary techniques of external beam radiotherapy in paediatric patients, based on the setting-up of a European, long-term registry complemented by a biobank.
Подробное описание
Specific objectives:
* 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.
Вмешательства
- Другое No intervention
No intervention
Первичные конечные точки
- Endocrinopathies [Срок оценки: up to 20 years after RT]
- Cardiovascular diseases [Срок оценки: up to 20 years after RT]
- Neurovascular diseases [Срок оценки: up to 20 years after RT]
- Second and subsequent primary neaoplasms [Срок оценки: up to 20 years after RT]
- Health-related quality of life (physical, emotional, social, and school functioning) assessed by the PedsQL™ core scale (validated questionnaire) [Срок оценки: up to 10 years after radiation therapy or attained age 25 years, whichever occurs first]
- Academic achievement [Срок оценки: up to 10 years after radiation therapy or attained age 25 years, whichever occurs first]
Вторичные конечные точки (11)
- Dysfunctions in endocrine hormone levels [Срок оценки: up to 10 years after radiation therapy]
- Changes in blood markers of cardiovascular diseases [Срок оценки: up to 10 years after radiation therapy]
- Changes in imaging markers of cardiovascular diseases [Срок оценки: up to 10 years after radiation therapy]
- Changes in imaging markers of neurovascular damages [Срок оценки: up to 5 years after radiation therapy]
- Changes in blood/saliva markers of protein activation relating to vascular damages [Срок оценки: up to 1 year after radiation therapy]
- Changes in blood/saliva markers of oxidative stress response [Срок оценки: up to 1 year after radiation therapy]
- Changes in blood/saliva markers of inflammatory response [Срок оценки: up to 1 year after radiation therapy]
- Changes in blood/saliva markers of carcinogenesis [Срок оценки: up to 1 year after radiation therapy]
- Multidimensional fatigue (general, sleep/rest, and cognitive fatigue) [Срок оценки: up to 10 years after radiation therapy or attained age 25 years, whichever occurs first]
- Clinical events other than those mentioned as primary outcomes [Срок оценки: up to 20 years after radiation therapy]
- All-cause and cause-specific mortality [Срок оценки: up to 20 years after radiation therapy]
Критерии участия
Retrospective inclusion of study participants
Критерии включения
- First external beam radiation therapy (EBRT) started in 2000 or after for management of a first primary neoplasm
- 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
Критерии исключения
- Patients with poor prognosis (e.g. diffuse pontine glioma or high grade glioma) at first EBRT initiation
- Prior external or internal radiation therapy
- Patients who refused to participate in the study
Prospective inclusion of study participants
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 2 центра
- Centre Régional François Baclesse — Caen
- Gustave Roussy — Villejuif
Бельгия · 1 центр
- KU Leuven — Leuven
Дания · 1 центр
- Aarhus University hospital — Aarhus
Германия · 1 центр
- University Hospital Essen, The West German Proton Therapy Centre Essen — Essen
Публикации
- 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 i PMID 37922994
Идентификаторы
NCT: NCT04746729 · C20-01 · 2020-A01037-32/1