Dienstag, 27. Juli 2021
Navigation öffnen
Anzeige:
Canakinumab
Canakinumab
 
JOURNAL ONKOLOGIE – STUDIE
HARMONIC-RT

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

Rekrutierend

NCT-Nummer:
NCT04746729

Studienbeginn:
März 2022

Letztes Update:
16.03.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

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

Collaborator:
Barcelona Institute for Global Health, The West German Proton Therapy Centre, Essen, Gustave Roussy, Cancer Campus, Grand Paris, Centre Francois Baclesse, KU Leuven, University of Aarhus, Princess Maxima Center for Pediatric Oncology, University Medical Center G

Studienleiter

Isabelle Thierry-chef, PhD
Study Director
Barcelona Institute for Global Health

Kontakt

Studienlocations
(3 von 5)

University Hospital Essen, The West German Proton Therapy Centre Essen
Essen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Martina Wette
E-Mail: martina.wette@uk-essen.de
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

Specific objectives:

- To develop the infrastructure and instruments for setting-up a European, long-term

registry of paediatric patients treated with modern external radiotherapy techniques ;

- To assess the incidence and severity of late health outcomes, primarily endocrine

dysfunctions, cardiovascular toxicities, neurovascular damages, and subsequent primary

neoplasms, in relation to the dose-volume distribution to non-targeted organs and

tissues, radiation delivery technique and beam quality factors, and potential modifying

factors (i.e. age at exposure, genetic predispositions, comorbidities, and systemic

treatments including chemotherapy, targeted therapy, immunotherapy and hormonal drugs)

that may underlie differences in individual susceptibility for these outcomes ;

- To assess societal aspects of advances in radiotherapy, primarily health-related quality

of life and academic achievement, in paediatric patients treated with modern external

radiotherapy techniques.

Secondary scientific objectives:

- To assess multidimensional fatigue in paediatric patients treated with modern external

radiotherapy techniques, and identify clinical and therapeutic determinants of fatigue;

- To improve estimation of patient-specific doses to the whole body and non-targeted

organs and substructures from different radiotherapy delivery techniques;

- To investigate radiation-induced cellular responses and biological mechanisms related to

the occurrence of vascular diseases and subsequent primary neoplasms in samples of blood

and saliva ; to identify biomarkers of susceptibility and health effects ; to evaluate

differences in disease biomarkers in relation to the radiation delivery technique and

beam quality factors ; to explore the relevance of the use of saliva as a biosampling

method for paediatric cohorts regarding feasibility and the quality and reproducibility

for different measured biomarkers.

Secondary strategic objectives:

- To promote sustained collaborative research activities for improvement of patient care,

and inform health care providers and policy makers on the clinical and social impact of

advances in radiotherapy in paediatric settings;

- To serve as a pilot for a future long-term pan-European registry of children and

adolescents treated with particle and photon beam therapy, including a biobank of saliva

and blood samples collected before and after treatment;

- To contribute in future collaborative projects with existing cohorts or registries in

Europe

- To contribute in future international research studies on late outcomes of modern

radiotherapy techniques for management of paediatric cancers

Funding: The HARMONIC project has received funding from the Euratom research and training

programme 2014-2018 under grant agreement No 847707.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Endocrinopathies (Time Frame - up to 20 years after RT):
Late health outcomes

2. Cardiovascular diseases (Time Frame - up to 20 years after RT):
Late health outcomes Neurovascular diseases Second and subsequent primary neaoplasms

3. Neurovascular diseases (Time Frame - up to 20 years after RT):
Late health outcomes

4. Second and subsequent primary neaoplasms (Time Frame - up to 20 years after RT):
Late health outcomes

5. Health-related quality of life (physical, emotional, social, and school functioning) assessed by the PedsQL™ core scale (validated questionnaire) (Time Frame - up to 10 years after radiation therapy or attained age 25 years, whichever occurs first):
Late social outcomes

6. Academic achievement (Time Frame - up to 10 years after radiation therapy or attained age 25 years, whichever occurs first):
Late social outcomes

Secondary outcome:

1. Dysfunctions in endocrine hormone levels (Time Frame - up to 10 years after radiation therapy):
measured as: insulin-like growth factor-1, anterior pituitary hormones (GH, ACTH, TSH, LH, FSH), thyroid hormones (fT3, fT4), sexual hormones

2. Changes in blood markers of cardiovascular diseases (Time Frame - up to 10 years after radiation therapy):
measured as blood markers (incl. troponin, BNP, CPK)

3. Changes in imaging markers of cardiovascular diseases (Time Frame - up to 10 years after radiation therapy):
measured as cardiac echography parameters (incl. ejection fraction, diastolic function)

4. Changes in imaging markers of neurovascular damages (Time Frame - up to 5 years after radiation therapy):
measured as scoring of large and small vessel damages

5. Changes in blood/saliva markers of protein activation relating to vascular damages (Time Frame - up to 1 year after radiation therapy):
measured as signal quality of protein activity

6. Changes in blood/saliva markers of oxidative stress response (Time Frame - up to 1 year after radiation therapy):
measured as markers of oxidative stress (incl. 8-oxo-dG, SOD2, DNA repair enzymes)

7. Changes in blood/saliva markers of inflammatory response (Time Frame - up to 1 year after radiation therapy):
Inflammatory markers (incl. PTX3, CRP, NF-kB, IL-1 and IL10)

8. Changes in blood/saliva markers of carcinogenesis (Time Frame - up to 1 year after radiation therapy):
Markers of carcinogenesis (incl. leukocyte telomere length, mitochondrial DNA copy number, circulating microRNA)

9. Multidimensional fatigue (general, sleep/rest, and cognitive fatigue) (Time Frame - up to 10 years after radiation therapy or attained age 25 years, whichever occurs first):
PedsQL™ multidimensional fatigue scale (validated questionnaire)

10. Clinical events other than those mentioned as primary outcomes (Time Frame - up to 20 years after radiation therapy):
Late morbidity

11. All-cause and cause-specific mortality (Time Frame - up to 20 years after radiation therapy):
Late mortality

Geprüfte Regime

  • No intervention:
    No intervention

Quelle: ClinicalTrials.gov


Das könnte Sie auch interessieren
EHA 2021
  • SCD: Häufigere und längere VOC-bedingte Krankenhausaufenthalte nach Vorgeschichte von VOC-Hospitalisierungen – Ergebnisse einer Beobachtungsstudie
  • Real-World-Daten des ERNEST-Registers untermauern Überlebensvorteil unter Ruxolitinib bei primärer und sekundärer Myelofibrose
  • I-WISh-Studie: Ärzte sehen TPO-RAs als beste Option, um anhaltende Remissionen bei ITP-Patienten zu erzielen
  • Phase-III-Studie REACH2 bei steroidrefraktärer akuter GvHD: Hohes Ansprechen auf Ruxolitinib auch nach Crossover
  • SCD: Neues digitales Schmerztagebuch zur tagesaktuellen Erfassung von VOCs wird in Beobachtungsstudie geprüft
  • Französische Real-World-Studie: Eltrombopag meist frühzeitig nach ITP-Diagnose im Rahmen eines Off-label-Use eingesetzt
  • Fortgeschrittene systemische Mastozytose: Französische Real-World-Studie bestätigt klinische Studiendaten zur Wirksamkeit von Midostaurin
  • CML-Management weitgehend leitliniengerecht, aber verbesserungsfähig – Ergebnisse einer Querschnittsbefragung bei britischen Hämatologen
  • Britische Real-World-Studie: Kardiovaskuläres Risikomanagement bei MPN-Patienten in der Primärversorgung nicht optimal
  • Myelofibrose: Früher Einsatz von Ruxolitinib unabhängig vom Ausmaß der Knochenmarkfibrose