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

Description du projet

De nouvelles perspectives pour le traitement du cancer du sein métastatique

Malgré l’émergence de technologies d’imagerie avancées telles que la TEP/TDM au FDG, les méthodes d’évaluation de la réponse au cancer du sein métastatique (CSM) sont demeurées obsolètes pendant des décennies. Cette stagnation est alarmante compte tenu de l’impact profond d’une stadification et d’un suivi précis sur les options thérapeutiques et la survie des patients. En outre, l’absence d’approches centrées sur le patient exacerbe le décalage entre les pratiques médicales et les réalités quotidienne des patientes souffrant de CSM. Dans ce contexte, le PREMIO COLLAB, financé par l’UE, se propose de moderniser l’évaluation des réponses. Dans le cadre d’un essai contrôlé randomisé multicentrique, il compare la surveillance basée sur la TEP/TDM au FDG et la TDM conventionnelle, en évaluant l’impact sur la survie et la qualité de vie. Il privilégie également le point de vue des patients, en intégrant la recherche participative pour affiner les flux de travail numériques. Avec l’imagerie optimisée par l’IA et les biopsies liquides, il promet des perspectives plus larges.

Objectif

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).”

Programme(s)

Coordinateur

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

Voir sur la carte

Région
Danmark Syddanmark Sydjylland
Type d’activité
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Liens
Coût total
€ 2 540 375,00

Participants (10)

Partenaires (2)