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NCT04746729Recruiting

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

Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy (HARMONIC-RT)

Source: ClinicalTrials.gov · Last updated 3 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
2670 (estimated)
First submitted
14 Sept 2020
Start date
11 Jan 2021
Primary completion date
30 Jan 2032
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
NCT number
NCT04746729

What you commit to

  • Study type: Observational
  • Planned participants: 2670
  • From 11 Jan 2021 to the primary completion date, 30 Jan 2032
  • 5 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior external or internal radiation therapy
  • Prior external or internal radiation therapy;

Other

  • Patients with poor prognosis (e.g. diffuse pontine glioma or high grade glioma) at first EBRT initiation
  • Patients who refused to participate in the study
    • Prospective inclusion of study participants
  • Patients with poor prognosis (e.g. diffuse pontine glioma or high grade glioma)
  • 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

Who the study is looking for

  • 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
  • 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

Criteria the registry did not label

  • Retrospective inclusion of study participants

Age in the registry: - to 22 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
KU Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumRecruiting
University Hospital Essen, The West German Proton Therapy Centre Essen
Coordinator of this site? Confirm its status
EssenGermanyRecruiting
Aarhus University Hospital
Coordinator of this site? Confirm its status
AarhusDenmarkRecruiting
Centre Regional Francois Baclesse
Coordinator of this site? Confirm its status
CaenFranceRecruiting
Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.