Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy
Recruiting now
Conditions studied: Neoplasms
In brief
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.
Key facts
- Study ID
- NCT04746729
- Run by
- Institut National de la Santé Et de la Recherche Médicale, France
- People needed
- 2670
- Starts
- 2021-01-11
- Expected to finish
- 2042-01-02
- Last updated by the study team
- 2026-08-03
Who can join
Age: any, up to 22. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- KU Leuven — Leuven, Belgium (enrolling)
- Aarhus University hospital — Aarhus, Denmark (enrolling)
- Centre Régional François Baclesse — Caen, France (enrolling)
- Gustave Roussy — Villejuif, France (enrolling)
- University Hospital Essen, The West German Proton Therapy Centre Essen — Essen, Germany (enrolling)
Full record on ClinicalTrials.gov
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