Actively Recruiting

Age: 0 - 22Years
All Genders
NCT04746729

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

Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2025-04-04

2670

Participants Needed

5

Research Sites

1028 weeks

Total Duration

On this page

Sponsors

I

Institut National de la Santé Et de la Recherche Médicale, France

Lead Sponsor

B

Barcelona Institute for Global Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 22Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Affiliate or beneficiary of health insurance or equivalent as defined by national law
  • Signed informed consent or assent
Not Eligible

You will not qualify if you...

  • Patients with poor prognosis such as 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
  • Protected adults under curatorship, tutorship, guardianship, or deprived of liberty
  • Adult, parent, or legal representative unable to read or understand the informed consent in applicable languages

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

KU Leuven

Leuven, Belgium

Actively Recruiting

2

Aarhus University hospital

Aarhus, Denmark

Actively Recruiting

3

Centre Régional François Baclesse

Caen, France

Actively Recruiting

4

Gustave Roussy

Villejuif, France

Actively Recruiting

5

University Hospital Essen, The West German Proton Therapy Centre Essen

Essen, Germany

Actively Recruiting

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Research Team

N

Neige Journy, PhD

CONTACT

B

Beate Timmermann, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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