Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy (HARMONIC-RT)

April 2, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy (HARMONIC-RT)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2670

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium
        • Recruiting
        • KU Leuven
        • Contact:
          • Sandra Jacobs
        • Contact:
        • Contact:
          • Karin Haustermans
        • Contact:
          • An Michiels
        • Contact:
          • Anne Uyttebroeck
        • Contact:
          • Karen Van Beek
        • Contact:
          • Melissa Christiaens
  • Denmark
      • Aarhus, Denmark
        • Recruiting
        • Aarhus University Hospital
        • Contact:
        • Contact:
          • Yasmin Lassen
        • Contact:
          • Sanja Karabegovic
        • Contact:
          • Louise Tram Henriksen
  • France
      • Caen, France
        • Recruiting
        • Centre Regional Francois Baclesse
        • Contact:
          • Juliette THARIAT, MD
        • Contact:
        • Contact:
          • Fernand Missohou, MD
        • Contact:
          • Jeanne Riverain, MD
        • Contact:
          • Jordan Bouter, MD
      • Villejuif, France
        • Recruiting
        • Gustave Roussy
        • Contact:
        • Contact:
          • Stéphanie Bolle
        • Contact:
          • Brice Fresneau
        • Contact:
          • Nadia Haddy
        • Contact:
          • Valentine Martin
  • Germany
      • Essen, Germany
        • Recruiting
        • University Hospital Essen, The West German Proton Therapy Centre Essen
        • Contact:
        • Contact:
          • Beate Timmermann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children, adolescents and young adults treated with external beam radiation therapy for a first primary neoplasm

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Endocrinopathies
Time Frame: up to 20 years after RT
Late health outcomes
up to 20 years after RT
Cardiovascular diseases
Time Frame: up to 20 years after RT

Late health outcomes

  • Neurovascular diseases
  • Second and subsequent primary neaoplasms
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dysfunctions in endocrine hormone levels
Time Frame: up to 10 years after radiation therapy

measured as:

  1. insulin-like growth factor-1,
  2. anterior pituitary hormones (GH, ACTH, TSH, LH, FSH),
  3. thyroid hormones (fT3, fT4),
  4. sexual hormones
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
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
Changes in imaging markers of neurovascular damages
Time Frame: up to 5 years after radiation therapy
measured as scoring of large and small vessel damages
up to 5 years after radiation therapy
Changes in blood/saliva markers of protein activation relating to vascular damages
Time Frame: up to 1 year after radiation therapy
measured as signal quality of protein activity
up to 1 year after radiation therapy
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
Changes in blood/saliva markers of carcinogenesis
Time Frame: up to 1 year after radiation therapy
Markers of carcinogenesis (incl. leukocyte telomere length, mitochondrial DNA copy number, circulating microRNA)
up to 1 year after radiation therapy
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut National de la Santé Et de la Recherche Médicale, France

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Zurich
Aarhus University Hospital
KU Leuven
University Hospital, Essen
University Medical Center Groningen
University of Aarhus
Princess Maxima Center for Pediatric Oncology
Gustave Roussy, Cancer Campus, Grand Paris
Barcelona Institute for Global Health
Commissariat A L'energie Atomique
Centre Francois Baclesse
Stockholm University
National Research Council, Institute of Clinical Physiology, Italy
Luxembourg Institute of Science and Technology
The West German Proton Therapy Centre, Essen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2040

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2040

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C20-01
  • 2020-A01037-32/1 (Registry Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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