- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04746729
Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy (HARMONIC-RT)
Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy (HARMONIC-RT)
Study Overview
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 (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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Neige Journy, PhD
- Phone Number: +33 142 11 54 27
- Email: neige.journy@gustaveroussy.fr
Study Contact Backup
- Name: Beate Timmermann, MD
- Phone Number: +49 201 723 64
- Email: beate.timmermann@uk-essen.de
Study Locations
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Leuven, Belgium
- Recruiting
- KU Leuven
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Contact:
- Sofie Isebaert
- Email: sofie.isebaert@uzleuven.be
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Principal Investigator:
- Karin Haustermans
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Sub-Investigator:
- An Michiels
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Sub-Investigator:
- Sandra Jacobs
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Sub-Investigator:
- Anne Uyttebroeck
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Sub-Investigator:
- Karen Van Beek
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Sub-Investigator:
- Melissa Christiaens
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-
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-
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Aarhus, Denmark
- Recruiting
- Aarhus University Hospital
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Contact:
- Yasmin Lassen
- Email: yasmin.lassen@auh.rm.dk
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Principal Investigator:
- Yasmin Lassen
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Sub-Investigator:
- Sanja Karabegovic
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Sub-Investigator:
- Louise Tram Henriksen
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-
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Caen, France
- Recruiting
- Centre Regional Francois Baclesse
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Principal Investigator:
- Juliette Thariat, MD
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Sub-Investigator:
- Fernand Missohou, MD
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Contact:
- Juliette Thariat, MD
- Email: j.thariat@baclesse.unicancer.fr
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Sub-Investigator:
- Jeanne Riverain, MD
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Sub-Investigator:
- Jordan Bouter, MD
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Villejuif, France
- Recruiting
- Gustave Roussy
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Principal Investigator:
- Stéphanie Bolle
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Sub-Investigator:
- Brice Fresneau
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Sub-Investigator:
- Nadia Haddy
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Contact:
- Stéphanie Bolle
- Email: Stephanie.Bolle@gustaveroussy.fr
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Sub-Investigator:
- Valentine Martin
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Essen, Germany
- Recruiting
- University Hospital Essen, The West German Proton Therapy Centre Essen
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Contact:
- Martina Wette
- Email: martina.wette@uk-essen.de
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Principal Investigator:
- Beate Timmermann
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endocrinopathies
Time Frame: up to 20 years after RT
|
Late health outcomes
|
up to 20 years after RT
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Cardiovascular diseases
Time Frame: up to 20 years after RT
|
Late health outcomes
|
up to 20 years after RT
|
Neurovascular diseases
Time Frame: up to 20 years after RT
|
Late health outcomes
|
up to 20 years after RT
|
Second and subsequent primary neaoplasms
Time Frame: up to 20 years after RT
|
Late health outcomes
|
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)
Time Frame: up to 10 years after radiation therapy or attained age 25 years, whichever occurs first
|
Late social outcomes
|
up to 10 years after radiation therapy or attained age 25 years, whichever occurs first
|
Academic achievement
Time Frame: up to 10 years after radiation therapy or attained age 25 years, whichever occurs first
|
Late social outcomes
|
up to 10 years after radiation therapy or attained age 25 years, whichever occurs first
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dysfunctions in endocrine hormone levels
Time Frame: up to 10 years after radiation therapy
|
measured as:
|
up to 10 years after radiation therapy
|
Changes in blood markers of cardiovascular diseases
Time Frame: up to 10 years after radiation therapy
|
measured as blood markers (incl.
troponin, BNP, CPK)
|
up to 10 years after radiation therapy
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Changes in imaging markers of cardiovascular diseases
Time Frame: up to 10 years after radiation therapy
|
measured as cardiac echography parameters (incl.
ejection fraction, diastolic function)
|
up to 10 years after radiation therapy
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Changes in imaging markers of neurovascular damages
Time Frame: up to 5 years after radiation therapy
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measured as scoring of large and small vessel damages
|
up to 5 years after radiation therapy
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Changes in blood/saliva markers of protein activation relating to vascular damages
Time Frame: up to 1 year after radiation therapy
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measured as signal quality of protein activity
|
up to 1 year after radiation therapy
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Changes in blood/saliva markers of oxidative stress response
Time Frame: up to 1 year after radiation therapy
|
measured as markers of oxidative stress (incl.
8-oxo-dG, SOD2, DNA repair enzymes)
|
up to 1 year after radiation therapy
|
Changes in blood/saliva markers of inflammatory response
Time Frame: up to 1 year after radiation therapy
|
Inflammatory markers (incl.
PTX3, CRP, NF-kB, IL-1 and IL10)
|
up to 1 year after radiation therapy
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Changes in blood/saliva markers of carcinogenesis
Time Frame: up to 1 year after radiation therapy
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Markers of carcinogenesis (incl.
leukocyte telomere length, mitochondrial DNA copy number, circulating microRNA)
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up to 1 year after radiation therapy
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Multidimensional fatigue (general, sleep/rest, and cognitive fatigue)
Time Frame: up to 10 years after radiation therapy or attained age 25 years, whichever occurs first
|
PedsQL™ multidimensional fatigue scale (validated questionnaire)
|
up to 10 years after radiation therapy or attained age 25 years, whichever occurs first
|
Clinical events other than those mentioned as primary outcomes
Time Frame: up to 20 years after radiation therapy
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Late morbidity
|
up to 20 years after radiation therapy
|
All-cause and cause-specific mortality
Time Frame: up to 20 years after radiation therapy
|
Late mortality
|
up to 20 years after radiation therapy
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Beate Timmermann, MD, UK Essen
- Principal Investigator: Neige Journy, PhD, Institut National de la Santé Et de la Recherche Médicale, France
- Principal Investigator: Stéphanie Bolle, MD, Gustave Roussy, Cancer Campus, Grand Paris
- Study Chair: Isabelle Thierry-chef, PhD, Barcelona Institute for Global Health
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C20-01
- 2020-A01037-32/1 (Registry Identifier: ID RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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