Evaluating health effects of modern radiotherapy in children
Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy (HARMONIC-RT)
Institut National de la Santé Et de la Recherche Médicale, France · NCT04746729
This study is trying to see how modern radiation therapy affects the long-term health and quality of life of children under 22 who have received or will receive this treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2670 (estimated) |
| Ages | N/A to 22 Years |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France (other gov) |
| Drugs / interventions | radiation, chemotherapy, immunotherapy |
| Locations | 5 sites (Leuven and 4 other locations) |
| Trial ID | NCT04746729 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients under 22 years old who have received or are scheduled to receive their first external beam radiation therapy for a primary neoplasm.
Not a fit: Patients with poor prognosis conditions or those who have previously undergone radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of late health effects in pediatric cancer survivors.
How similar studies have performed: Other studies have shown success in evaluating late effects of radiotherapy in pediatric populations, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Leuven and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neoplasms, Radiotherapy, Oncology, Paediatrics, Late toxicities, Radiation-induced neoplasms, Radiation-induced vascular damages, Radiation-induced cardiac damages