RecruitingNot Applicable

Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy

Belgium, Denmark, France2,670 participantsStarted 2021-01-11

Plain-language 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.

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 EB…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Endocrinopathies

Timeframe: up to 20 years after RT

Cardiovascular diseases

Timeframe: up to 20 years after RT

Neurovascular diseases

Timeframe: up to 20 years after RT

Second and subsequent primary neaoplasms

Timeframe: up to 20 years after RT

Health-related quality of life (physical, emotional, social, and school functioning) assessed by the PedsQL™ core scale (validated questionnaire)

Timeframe: up to 10 years after radiation therapy or attained age 25 years, whichever occurs first

Academic achievement

Timeframe: up to 10 years after radiation therapy or attained age 25 years, whichever occurs first

Trial details

NCT IDNCT04746729

SponsorInstitut National de la Santé Et de la Recherche Médicale, France

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2032-01-30

Contact for this trial

Neige Journy, PhD

+33 142 11 54 27 neige.journy@gustaveroussy.fr

View on ClinicalTrials.gov More Neoplasms trials

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Endocrinopathies

Timeframe: up to 20 years after RT

Cardiovascular diseases

Timeframe: up to 20 years after RT

Neurovascular diseases

Timeframe: up to 20 years after RT

Second and subsequent primary neaoplasms

Timeframe: up to 20 years after RT

Health-related quality of life (physical, emotional, social, and school functioning) assessed by the PedsQL™ core scale (validated questionnaire)

Timeframe: up to 10 years after radiation therapy or attained age 25 years, whichever occurs first

Academic achievement

Timeframe: up to 10 years after radiation therapy or attained age 25 years, whichever occurs first