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

ConditionNeoplasms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 22
SponsorInstitut National de la Santé Et de la Recherche Médicale, France

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Scheduled first EBRT for management of a first primary neoplasm

Trial population

Children, adolescents and young adults treated with external beam radiation therapy for a first primary neoplasm

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • No intervention

    Other intervention

    No intervention

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Endocrinopathies

Late health outcomes

Time frame
up to 20 years after RT
2

Cardiovascular diseases

Late health outcomes * Neurovascular diseases * Second and subsequent primary neaoplasms

Time frame
up to 20 years after RT
3

Neurovascular diseases

Late health outcomes

Time frame
up to 20 years after RT
4

Second and subsequent primary neaoplasms

Late health outcomes

Time frame
up to 20 years after RT

Secondary outcomes

1

Dysfunctions in endocrine hormone levels

measured as: 1. insulin-like growth factor-1, 2. anterior pituitary hormones (GH, ACTH, TSH, LH, FSH), 3. thyroid hormones (fT3, fT4), 4. sexual hormones

Time frame
up to 10 years after radiation therapy
2

Changes in blood markers of cardiovascular diseases

measured as blood markers (incl. troponin, BNP, CPK)

Time frame
up to 10 years after radiation therapy
3

Changes in imaging markers of cardiovascular diseases

measured as cardiac echography parameters (incl. ejection fraction, diastolic function)

Time frame
up to 10 years after radiation therapy
4

Changes in imaging markers of neurovascular damages

measured as scoring of large and small vessel damages

Time frame
up to 5 years after radiation therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Barcelona Institute for Global Health

Collaborator

The West German Proton Therapy Centre, Essen

Collaborator

Gustave Roussy, Cancer Campus, Grand Paris

Collaborator

Centre Francois Baclesse

Collaborator

KU Leuven

Collaborator

University of Aarhus

Collaborator

Princess Maxima Center for Pediatric Oncology

Collaborator

University Medical Center Groningen

Collaborator

Stockholm University

Collaborator

National Research Council, Institute of Clinical Physiology, Italy

Collaborator

University of Zurich

Collaborator

Commissariat A L'energie Atomique

Collaborator

Luxembourg Institute of Science and Technology

Collaborator

University Hospital, Essen

Collaborator

Aarhus University Hospital

Collaborator