Scroll Top

IMPLEMENTATION OF MARKERS IN THE CLINIC – FROM SINGLE TO COMPOSITE BIOMARKER

COORDONATORS
female-silhouette-768x614
Laure Fournier, MD, PhD
female-silhouette-768x614
Franck Pagès, MD, PhD

The aim of this program is to implement biomarkers in routine care, with the potential to modify the management of cancer patients. The integration of multidimensional analyses from program 1 (omics, imaging, etc.) with care data will be achieved through the creation of an integrative database (C-MOT). It will enable the validation of clinical decision support tools using all the data produced. This validation will cover both analytical and clinical aspects, to meet regulatory requirements for validation of clinical utility through clinical trials. This program will enable the diagnostics industry to validate their tests under real-life conditions.

Applying the results of translational research to everyday clinical practice is a real challenge today. Through the experience of the first 2 CARPEM programs, we have identified a number of obstacles to the implementation of precision medicine, not least the lack of an integrative database capable of collecting, structuring and analyzing all data from both care and research. The integration of multi-scale analyses carried out by CARPEM’s research teams (IRP1) with healthcare data is essential to validate the clinical usefulness of identified biomarkers through clinical trials.

This project will benefit from the expertise of CARPEM teams in the development of biomarkers based on different techniques: genomics, transcriptomic analysis, circulating tumor DNA, immunohistochemistry or radiomics, in different tumor types1.

1Jouinot et al. Eur J Endocrinol. 2022,, Neou et al. Cancer Cell 2020, Assié et al. JAMA Oncol 2019, Liu P Nature Comm 2019, Bondu et al. Sci Transl Med 2019, Karaki et al. J Immunother Cancer 2021, Italiano et al. Nature Medicine 2021, Petitprez et al. Nature 2000, Marisa et al. Clin Cancer Res, 2022, Vano et al. Lancet Oncol 2022, Beinse et al. Br J Cancer 2022, Meylan et al. Immunity 2022, Zhao et al. Clin Cancer Res 2021, Laurent-Puig et al. Clin Cancer Res 2020, Beinse et al. Clin Chem 2022, Taieb et al. Clin Cancer Res 2021, Bachet Clin Cancer Res 2020, Rossignol et al. iScience. 2022, Pages et al. Lancet 2018, Pages et al. Ann Oncol 2020, Rousseau B et al. Cancer Discov 2022, Decroocq et al. Leukemia 2022, Roblot et al. Eur Radiol 2022, Fournier et al. Eur Radiol 2021, Lussey-Lepoutre et al. Eur J Nucl Med Mol Imaging. 2020, Touzart et al. Sci Transl Med 2021

This research program is divided into 4 workpackages.

WP4 “Structuring and implementation of C-MOT”. This workpackage is dedicated to the deployment of the integrative database (C-MOT), in compliance with current legislation. C-MOT will increase the attractiveness of our CARPEM network for developing collaborative research programs (inter-SIRIC, industrial partnerships, etc.).

WP5 “Validation of biomarkers identified by CARPEM”. This workpackage aims to confirm and extend the validation of biomarkers previously or newly identified by CARPEM (for diagnostic, prognostic, therapeutic screening or treatment response prediction purposes) on large cohorts of patients.

WP6 “Analytical validation of identified markers to meet current regulations for diagnostic tests”. This workpackage aims to carry out analytical validation of the biomarkers identified. Validation of analytical assays involves assessing performance characteristics such as precision, accuracy, limit of detection and robustness. The biomarker qualification procedure has been set up by the European Medicines Agency.

WP7 “Implementation of markers in routine clinical practice and clinical trials to validate their clinical utility”. This workpackage is dedicated to the implementation of biomarkers validated in WP5 and WP6 in routine clinical practice at the Institut du Cancer Paris CARPEM.