About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Scheduled first EBRT for management of a first primary neoplasm
Trial population
Children, adolescents and young adults treated with external beam radiation therapy for a first primary neoplasm
Trial design
Cohort
Other
Treatments tested in this trial
No intervention
Other interventionNo intervention
Treatment groups
Trial outcomes
Primary outcomes
Endocrinopathies
Late health outcomes
Cardiovascular diseases
Late health outcomes * Neurovascular diseases * Second and subsequent primary neaoplasms
Neurovascular diseases
Late health outcomes
Second and subsequent primary neaoplasms
Late health outcomes
Secondary outcomes
Dysfunctions in endocrine hormone levels
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
Changes in blood markers of cardiovascular diseases
measured as blood markers (incl. troponin, BNP, CPK)
Changes in imaging markers of cardiovascular diseases
measured as cardiac echography parameters (incl. ejection fraction, diastolic function)
Changes in imaging markers of neurovascular damages
measured as scoring of large and small vessel damages
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Institut National de la Santé Et de la Recherche Médicale, France
Lead sponsor
Barcelona Institute for Global Health
Collaborator
The West German Proton Therapy Centre, Essen
Collaborator
Gustave Roussy, Cancer Campus, Grand Paris
Collaborator
Centre Francois Baclesse
Collaborator
KU Leuven
Collaborator
University of Aarhus
Collaborator
Princess Maxima Center for Pediatric Oncology
Collaborator
University Medical Center Groningen
Collaborator
Stockholm University
Collaborator
National Research Council, Institute of Clinical Physiology, Italy
Collaborator
University of Zurich
Collaborator
Commissariat A L'energie Atomique
Collaborator
Luxembourg Institute of Science and Technology
Collaborator
University Hospital, Essen
Collaborator
Aarhus University Hospital
Collaborator