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Personalised response monitoring in oncology: co-creating clinical trials in advanced breast cancer

Descrizione del progetto

Nuove prospettive di cura del tumore al seno metastatico

Nonostante l’emergere di tecnologie di imaging avanzate come la FDG-PET/CT, i metodi di valutazione della risposta per il carcinoma mammario metastatico (MBC) sono rimasti obsoleti per decenni. Questo ristagno è allarmante se si considera il profondo impatto che una stadiazione e un monitoraggio accurati hanno sulle opzioni terapeutiche e sulla sopravvivenza delle pazienti. Inoltre, la mancanza di approcci incentrati sul paziente esaspera il divario tra le pratiche mediche e la realtà della convivenza con l’MBC. In questo contesto, il PREMIO COLLAB, finanziato dall’UE, intende modernizzare la valutazione delle risposte. Attraverso una sperimentazione clinica randomizzata multicentrica, confronta il monitoraggio basato sulla FDG-PET/CT con la TC convenzionale, valutando l’impatto sulla sopravvivenza e sulla qualità di vita. Inoltre, dà priorità alle prospettive delle pazienti, integrando la ricerca partecipativa per perfezionare i flussi di lavoro digitali. Con l’imaging guidato dall’intelligenza artificiale e le biopsie liquide, promette approfondimenti più ampi.

Obiettivo

PREMIO COLLAB’s vision is to prolong overall survival and improve the quality of life for patients with metastatic breast cancer (MBC) by providing refined guidance for managing response monitoring. PREMIO COLLAB strives to facilitate improved patient care and streamlined clinical workflows addressing the needs of patients, healthcare professionals, and society.
Response evaluation methods for patients with MBC have not been modernised for decades, although molecular imaging with FDG-PET/CT has emerged as a highly accurate method for staging MBC, and staging and monitoring MBC has a profound influence on treatment options and the chances of survival. Furthermore, the patient perspective has rarely been considered, although continuous response evaluation in a monitoring setting has interacted with the life of MBC patients for years. Still, no specific recommendations are provided internationally for response evaluation in MBC or in the overall management of monitoring.
PREMIO COLLAB offers complementary competencies in an interdisciplinary collaborative effort to lift this complex task. In a pragmatic multicenter randomised clinical trial (RCT), we will apply the intervention of FDG-PET/CT-based monitoring and compare it with conventional CT as state-of-the-art. The objectives are to analyse the impact of the intervention on overall survival and quality of life in patients with MBC and include cost-effectiveness analyses directly informing HTA agencies and health policymakers. Building on knowledge from the RCT, we will use participatory research designs to develop improved and modernised patient pathways and digital workflows. AI-based solutions in imaging and liquid biopsies constitute perspectives with a broader horizon.
The work will be done in multiple European centres and living labs with patient representatives, clinicians, and relevant stakeholders aiming to provide knowledge for updated recommendations with a view to subsequent clinical implementation.
This action is part of the Cancer Mission cluster of projects on ‘‘Diagnostics and Treatment (diagnostics).”

Programma(i)

Coordinatore

REGION SYDDANMARK
Contribution nette de l'UE
€ 2 535 375,00
Indirizzo
DAMHAVEN 12
7100 Vejle
Danimarca

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Regione
Danmark Syddanmark Sydjylland
Tipo di attività
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Collegamenti
Costo totale
€ 2 540 375,00

Partecipanti (10)

Partner (2)