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Clinical Trials in Germany / NCT04746729
Recruiting Observational

Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy

NCT04746729 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2021-01-11
Last updated
2026-08-03

Condition(s) studied

Neoplasms

Investigational drug(s) / intervention(s)

No intervention

No intervention: No intervention

Study summary

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)

Trial sites (5)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT04746729 on ClinicalTrials.gov ↗ ← All trials in Germany