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

NCT04746729 | Recruiting DMC

• 2 other identifiers: C20-012020-A01037-32/1
• Study Type: observational
• Target: 2,670
• Locations: 4 countries
• Sites: 5

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.

Conditions

Neoplasms

Keywords

Radiotherapy; Oncology; Paediatrics; Late toxicities; Radiation-induced neoplasms; Radiation-induced vascular damages; Radiation-induced cardiac damages; Radiation-induced endocrine damages; Quality of life; Social outcomes; External beam radiotherapy; Photon therapy; Proton therapy; Cohort; Registry

Outcome Measures

Primary Outcomes (6)

• Endocrinopathies

  Late health outcomes

  up to 20 years after RT

• Cardiovascular diseases

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

  up to 20 years after RT

• Neurovascular diseases

  Late health outcomes

  up to 20 years after RT

• Second and subsequent primary neaoplasms

  Late health outcomes

  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)

  Late social outcomes

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

• Academic achievement

  Late social outcomes

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

Secondary Outcomes (11)

• Dysfunctions in endocrine hormone levels

  up to 10 years after radiation therapy

• Changes in blood markers of cardiovascular diseases

  up to 10 years after radiation therapy

• Changes in imaging markers of cardiovascular diseases

  up to 10 years after radiation therapy

• Changes in imaging markers of neurovascular damages

  up to 5 years after radiation therapy

• Changes in blood/saliva markers of protein activation relating to vascular damages

  up to 1 year after radiation therapy

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: Up to 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• 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

Study Sites (5)

KU Leuven

Leuven, Belgium

RECRUITING

Aarhus University hospital

Aarhus, Denmark

RECRUITING

Centre Régional François Baclesse

Caen, France

RECRUITING

Gustave Roussy

Villejuif, France

RECRUITING

University Hospital Essen, The West German Proton Therapy Centre Essen

Essen, Germany

RECRUITING

Related Publications (1)

• Journy 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 BACKGROUND

Related Links

• Project's website

Biospecimen

Retention: SAMPLES WITH DNA

blood plasma; blood serum; lymphocytes; saliva

MeSH Terms

Conditions

Neoplasms; Neoplasms, Radiation-Induced

Condition Hierarchy (Ancestors)

Radiation Injuries; Wounds and Injuries

Study Officials

• Beate Timmermann, MD

  UK Essen

  PRINCIPAL INVESTIGATOR

• Neige Journy, PhD

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

  PRINCIPAL INVESTIGATOR

• Stéphanie Bolle, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

• Isabelle Thierry-chef, PhD

  Barcelona Institute for Global Health

  STUDY CHAIR

Central Study Contacts

Neige Journy, PhD

CONTACT

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

Beate Timmermann, MD

CONTACT

+49 201 723 64; beate.timmermann@uk-essen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 20 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: February 10, 2021
• Study Start: January 11, 2021
• Primary Completion (Estimated): September 30, 2040
• Study Completion (Estimated): September 30, 2040
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

FR (2); DE (1); BE (1); DK (1)