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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (5 locations)

1

KU Leuven

Leuven, Belgium

2

Aarhus University hospital

Aarhus, Denmark

3

Centre Régional François Baclesse

Caen, France

4

Gustave Roussy

Villejuif, France