Status:
RECRUITING
Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsors:
Barcelona Institute for Global Health
The West German Proton Therapy Centre, Essen
Conditions:
Neoplasms
Eligibility:
All Genders
Up to 22 years
Brief 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,...
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 radio...
Eligibility Criteria
Inclusion
- Retrospective inclusion of study participants
- 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
- 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
Key Trial Info
Start Date :
January 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2040
Estimated Enrollment :
2670 Patients enrolled
Trial Details
Trial ID
NCT04746729
Start Date
January 11 2021
End Date
September 30 2040
Last Update
April 4 2025
Active Locations (5)
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1
KU Leuven
Leuven, Belgium
2
Aarhus University hospital
Aarhus, Denmark
3
Centre Régional François Baclesse
Caen, France
4
Gustave Roussy
Villejuif, France