NCT04746729招募中不适用
Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy (HARMONIC-RT)
Institut National de la Santé Et de la Recherche Médicale, France5 个研究点 分布在 4 个国家目标入组 2,670 人开始时间: 2021年1月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,670
- 试验地点
- 5
- 主要终点
- Academic achievement
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retrospective inclusion of study participants
- •Inclusion Criteria:
- •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
排除标准
- •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
- •Inclusion Criteria:
- •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:
- •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
结局指标
主要结局
Academic achievement
时间窗: up to 10 years after radiation therapy or attained age 25 years, whichever occurs first
Late social outcomes
Neurovascular diseases
时间窗: up to 20 years after RT
Late health outcomes
Second and subsequent primary neaoplasms
时间窗: up to 20 years after RT
Late health outcomes
Health-related quality of life (physical, emotional, social, and school functioning) assessed by the PedsQL™ core scale (validated questionnaire)
时间窗: up to 10 years after radiation therapy or attained age 25 years, whichever occurs first
Late social outcomes
Cardiovascular diseases
时间窗: up to 20 years after RT
Late health outcomes * Neurovascular diseases * Second and subsequent primary neaoplasms
Endocrinopathies
时间窗: up to 20 years after RT
Late health outcomes
次要结局
- Changes in blood/saliva markers of oxidative stress response(up to 1 year after radiation therapy)
- Clinical events other than those mentioned as primary outcomes(up to 20 years after radiation therapy)
- Changes in imaging markers of neurovascular damages(up to 5 years after radiation therapy)
- Changes in blood/saliva markers of carcinogenesis(up to 1 year after radiation therapy)
- Multidimensional fatigue (general, sleep/rest, and cognitive fatigue)(up to 10 years after radiation therapy or attained age 25 years, whichever occurs first)
- All-cause and cause-specific mortality(up to 20 years after radiation therapy)
- Changes in blood markers of cardiovascular diseases(up to 10 years after radiation therapy)
- Changes in blood/saliva markers of protein activation relating to vascular damages(up to 1 year after radiation therapy)
- Changes in imaging markers of cardiovascular diseases(up to 10 years after radiation therapy)
- Dysfunctions in endocrine hormone levels(up to 10 years after radiation therapy)
- Changes in blood/saliva markers of inflammatory response(up to 1 year after radiation therapy)
研究者
研究点 (5)
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