Evaluating health effects of modern radiotherapy in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The HARMONIC-RT study aims to create a long-term registry of pediatric patients treated with contemporary external beam radiotherapy techniques. It will assess late health outcomes, including endocrine dysfunctions and cardiovascular toxicities, as well as societal impacts like quality of life and academic achievement. The study will also investigate factors influencing individual susceptibility to these outcomes and explore the biological mechanisms behind radiation-induced diseases. This observational study will include both retrospective and prospective participants under the age of 22 who have undergone or are scheduled for their first external beam radiation therapy.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Principal investigator: Beate Timmermann, MD — UK Essen
• Study coordinator: Neige Journy, PhD
• Email: neige.journy@gustaveroussy.fr
• Phone: +33 142 11 54 27

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.