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
Sex
ALL
Min age
—
Max age
22 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Endocrinopathies — up to 20 years after RT Late health outcomes
Cardiovascular diseases — up to 20 years after RT Late health outcomes
* Neurovascular diseases
* Second and subsequent primary neaoplasms
Neurovascular diseases — up to 20 years after RT Late health outcomes
Second and subsequent primary neaoplasms — 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) — up to 10 years after radiation therapy or attained age 25 years, whichever occurs first Late social outcomes
Academic achievement — up to 10 years after radiation therapy or attained age 25 years, whichever occurs first Late social outcomes
Trial sites (5)
Facility
City
Region
Status
KU Leuven
Leuven
Belgium
Recruiting
Aarhus University hospital
Aarhus
Denmark
Recruiting
Centre Régional François Baclesse
Caen
France
Recruiting
Gustave Roussy
Villejuif
France
Recruiting
University Hospital Essen, The West German Proton Therapy Centre Essen
Essen
Germany
Recruiting
More Institut National de la Santé Et de la Recherche Médicale, France trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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