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Residual disease assessment in hematologic malignancies to improve patient-relevant outcomes across Europe (RESOLVE)

Descripción del proyecto

Medicina de precisión para el tratamiento de la leucemia

En el ámbito de la leucemia, la detección de la enfermedad mínima residual (EMR) sigue siendo fundamental, aunque su potencial como biomarcador de guía del tratamiento sigue sin conocerse. En este contexto, el proyecto RESOLVE, financiado con fondos europeos, reunirá a redes de expertos y asociaciones de pacientes para validar el valor predictivo de la EMR en personas con leucemia mielógena aguda y leucemia linfática crónica. El equipo del proyecto elaborará un registro de pacientes y efectuará un análisis descentralizado de la EMR y un ensayo multinacional para, de este modo, personalizar la intensidad de la terapia y mejorar así la calidad de vida y reducir los costes. RESOLVE se basa en un planteamiento de investigación participativa y una difusión abierta, a fin de garantizar una amplia aplicabilidad y transformar la evaluación de la EMR en una práctica clínica convencional. Esta iniciativa se alinea con el grupo de diagnóstico y tratamiento de la misión contra el cáncer y constituye un paso fundamental hacia la medicina de precisión.

Objetivo

"MeMeasurable residual disease (MRD) detected by multiparameter flow cytometry (MFC) has strong prognostic value in patients with the most frequent acute and chronic leukemias, acute myeloid (AML) and chronic lymphocytic leukemia (CLL), but it has not yet been confirmed as a treatment-guiding biomarker. The RESOLVE Consortium will leverage numerous existing expert networks and patient advocacy partnerships to establish the predictive value of MRD in AML/CLL patients, with the expectation that this affordable, minimally-invasive biomarker can be imminently used to guide the intensity of consolidation therapy, improve quality of life (QoL), and reduce costs. This will be achieved through 1) development of a real-world patient registry and data platform; 2) establishment of standardized, decentralized MRD analysis across Europe; and 3) a randomized, controlled multi-national pragmatic trial based on the hypothesis that treatment intensity can be safely reduced in MRD negative AML/CLL patients, to provide evidence for the clinical, personal and societal impact of MRD-guided therapy. These efforts will be supported by RESOLVE’s participatory research pipeline, which will incorporate input from patients, caregivers, and experts in social sciences and health economics. The real-world nature of the study ensures broadly applicable results for all patients regardless of location, socioeconomic status, gender, sex, disability or ethnicity. The findings will then be effectively communicated and disseminated following open science principles through the medical community for uptake in routine clinical practice. The laboratory, clinical, and patient advocacy infrastructures already in place will support rapid adoption of MFC-based MRD assessment to aid in clinical decision-making. The Consortium’s widespread member organizations will work with policymakers and authorities across the EU to provide access to the test in the national health care systems for all AML and CLL patients.
This action is part of the Cancer Mission cluster of projects ""Diagnostics and Treatment (diagnostics)""."

Programa(s)

Coordinador

MEDIZINISCHE HOCHSCHULE HANNOVER
Aportación neta de la UEn
€ 2 188 010,00
Dirección
Carl-Neuberg-Strasse 1
30625 Hannover
Alemania

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Región
Niedersachsen Hannover Region Hannover
Tipo de actividad
Higher or Secondary Education Establishments
Enlaces
Coste total
€ 2 188 010,00

Participantes (20)