NCT04746729 Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy
| NCT ID | NCT04746729 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
| Condition | Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,670 participants |
| Start Date | 2021-01-11 |
| Primary Completion | 2040-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,670 participants in total. It began in 2021-01-11 with a primary completion date of 2040-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, long-term registry complemented by a biobank.
Eligibility 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
Contact & Investigator
Beate Timmermann, MD
PRINCIPAL INVESTIGATOR
UK Essen
Frequently Asked Questions
Who can join the NCT04746729 clinical trial?
This trial is open to participants of all sexes, up to 22 Years, studying Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04746729 currently recruiting?
Yes, NCT04746729 is actively recruiting participants. Contact the research team at neige.journy@gustaveroussy.fr for enrollment information.
Where is the NCT04746729 trial being conducted?
This trial is being conducted at Leuven, Belgium, Aarhus, Denmark, Caen, France, Villejuif, France and 1 additional location.
Who is sponsoring the NCT04746729 clinical trial?
NCT04746729 is sponsored by Institut National de la Santé Et de la Recherche Médicale, France. The principal investigator is Beate Timmermann, MD at UK Essen. The trial plans to enroll 2,670 participants.