Clinical trial · Observational
Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy
Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy (HARMONIC-RT)
NCT04746729CI-TRIAL-00120318HARMONIC-RTrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Endocrinopathies
- timeFrame
- up to 20 years after RT
- description
- Late health outcomes
- measure
- Cardiovascular diseases
- timeFrame
- up to 20 years after RT
- description
- Late health outcomes * Neurovascular diseases * Second and subsequent primary neaoplasms
- measure
- Neurovascular diseases
- timeFrame
- up to 20 years after RT
- description
- Late health outcomes
- measure
- Second and subsequent primary neaoplasms
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 22 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDJourny N, Bolle S, Brualla L, Dumas A, Fresneau B, Haddy N, Haghdoost S, Haustermans K, Jackson A, Karabegovic S, Lassen-Ramshad Y, Thariat J, Wette MR, Botzenhardt S, De Wit I, Demoor-Goldschmidt C, Christiaens M, Hoyer M, Isebaert S, Jacobs S, Henriksen LT, Maduro JH, Ronckers C, Steinmeier T, Uyttebroeck A, Van Beek K, Walsh L, Thierry-Chef I, Timmermann B. Assessing late outcomes of advances in radiotherapy for paediatric cancers: Study protocol of the "HARMONIC-RT" European registry (NCT 04746729). Radiother Oncol. 2024 Jan;190:109972. doi: 10.1016/j.radonc.2023.109972. Epub 2023 Nov 2. No abstract available. PMID 37922994