Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04746729
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2020-09-14
Brief Title:
Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy
Sponsor:
Institut National de la Santé Et de la Recherche Médicale France
Organization:
Institut National de la Santé Et de la Recherche Médicale France
Study Overview
Official Title:
Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy HARMONIC-RT
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HARMONIC-RT
Brief Summary:
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
Detailed Description:
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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A01037-321 | REGISTRY | ID RCB | None |