NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

RecruitingN/A

Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Conditions: Neoplasms

Interventions: No intervention

Countries: Belgium, Denmark, France, Germany

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 overview

Sex: ALL

Age: — to 22 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (5)

Leuven, Belgium
Aarhus, Denmark
Caen, France
Villejuif, France
Essen, Germany