Biomarkers affecting the transition from cardiovascular disease to lung cancer: towards stratified interception.

Informations projet

PREVALUNG EU

N° de convention de subvention: 101095604

DOI

10.3030/101095604

Date de signature de la CE 24 Novembre 2022

Date de début 1 Decembre 2022

Date de fin 30 Novembre 2027

Financé au titre de

• Health

Coût total

€ 7 166 124,25

Contribution de l’UE

€ 7 016 124,00

Coordonné par

INSTITUT GUSTAVE ROUSSY
France

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Livrables

Documents, reports (27)

Communication and dissemination plan: Details on the dissemination strategy and action plan including analysis of stakeholder groups, identification of key events and activities

Communication and dissemination plan: Details on the dissemination strategyand action plan including analysis of stakeholder groups, identification of keyevents and activities

Project Quality Plan (PQP): rules for meetings management, documents naming and storage, deliverables preparation and quality review

Project Quality Plan (PQP): rules for meetings management, documents namingand storage, deliverables preparation and quality review

Study initiation package – RISP

Study initiation package-RISP (before enrolment of the first study participant) including:oRegistration number of the clinical study in a registry meeting WHO Registry criteriaoFinal version of study protocol as approved by the regulator(s) / ethics committee(s)oRegulatory and ethics (if applicable, institutional) approvals required for the enrolment of the first study participant (In case of multicentre clinical studies, submission of approvals for the first clinical site is sufficient.)

Midterm recruitment report – PREVALUNG ETOILE

Midterm recruitment report-PREVALUNG ETOILE: This report is due when 50% of the study population is recruited. The report shall include an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.

Project Management Plan (PMP): organisation, scope of work, Master Plan, Project Action List, risk register

Project Management Plan (PMP): organisation, scope of work, Master Plan,Project Action List, risk register

First meeting of the PAB minutes
Publication on the performance of PREVALUNG-EU classifiers based on PREVALUNG France and retrospective exploitation of FLEMENGHO, ROBINSCA and SUMMIT.

Publication on the performance of PREVALUNG-EU classifiers based onPREVALUNG France and retrospective exploitation of FLEMENGHO, ROBINSCA and SUMMIT.

Report on the status of posting results in a repository – FLEMENGHO

Report on the status of posting results in a repository-FLEMENGHO. Irrespective of the successful completion of the clinical study, summary results must be posted in the applicable registry/ies (where the study was registered) even if the timing of posting of results falls outside of the grant period. The report is to be scheduled for the time results posting is expected or for the last months of the project, whichever comes earlier.

Midterm recruitment report – SUMMIT

Midterm recruitment report-SUMMIT: This report is due when 50% of the study population is recruited. The report shall include an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.

Management Board charts signed by members
Study initiation package – PREVALUNG BIOCEPTION

Prepared before enrolment of the first study participant, the report includes: • Registration number of the clinical study in a registry meeting WHO Registry criteria • Final version of study protocol as approved by the regulator(s) / ethics committee(s) • Regulatory and ethics (if applicable, institutional) approvals required for the enrolment of the first study participant (In case of multicentre clinical studies, submission of approvals for the first clinical site is sufficient.)

Report on the status of posting results in a repository – PREVALUNG

Report on the status of posting results in a repository-PREVALUNG. Irrespective of the successful completion of the clinical study, summary results must be posted in the applicable registry/ies (where the study was registered) even if the timing of posting of results falls outside of the grant period. The report is to be scheduled for the time results posting is expected or for the last months of the project, whichever comes earlier.

Midterm recruitment report – PREVALUNG

Midterm recruitment report- PREVALUNG: This report is due when 50% of the study population is recruited. The report shall include an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.

Midterm recruitment report – ROBINSCA

Midterm recruitment report-ROBINSCA: This report is due when 50% of the study population is recruited. The report shall include an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.

Report on the traceability of samples and biomarker monitoring
Study initiation package – SUMMIT

Study initiation package-SUMMIT (before enrolment of the first study participant) including:oRegistration number of the clinical study in a registry meeting WHO Registry criteriaoFinal version of study protocol as approved by the regulator(s) / ethics committee(s)oRegulatory and ethics (if applicable, institutional) approvals required for the enrolment of the first study participant (In case of multicentre clinical studies, submission of approvals for the first clinical site is sufficient.)

Prospective technical implementation of the user- friendly Bio-Me filter-cards for the diagnosis of stool dysbiosis

Prospective technical implementation of the user- friendly Bio-Me filter-cardsfor the diagnosis of stool dysbiosis

Study initiation package – FLEMENGHO

Study initiation package-FLEMENGHO (before enrolment of the first study participant) including:oRegistration number of the clinical study in a registry meeting WHO Registry criteriaoFinal version of study protocol as approved by the regulator(s) / ethics committee(s)oRegulatory and ethics (if applicable, institutional) approvals required for the enrolment of the first study participant (In case of multicentre clinical studies, submission of approvals for the first clinical site is sufficient.)

Midterm recruitment report – RISP

Midterm recruitment report- RISP: This report is due when 50% of the study population is recruited. The report shall include an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.

Report and/or publication on the performance of the classifiers and statistics for each classifier and interdependency/interaction in between classifiers

Report and/or publication on the performance of the classifiers and statistics foreach classifier and interdependency/interaction in between classifiers

Study initiation package – PREVALUNG ETOILE

Study initiation package-PREVALUNG ETOILE (before enrolment of the first study participant) including:oRegistration number of the clinical study in a registry meeting WHO Registry criteriaoFinal version of study protocol as approved by the regulator(s) / ethics committee(s)oRegulatory and ethics (if applicable, institutional) approvals required for the enrolment of the first study participant (In case of multicentre clinical studies, submission of approvals for the first clinical site is sufficient.)

Study initiation package – ROBINSCA

•Study initiation package-ROBINSCA (before enrolment of the first study participant) including:oRegistration number of the clinical study in a registry meeting WHO Registry criteriaoFinal version of study protocol as approved by the regulator(s) / ethics committee(s)oRegulatory and ethics (if applicable, institutional) approvals required for the enrolment of the first study participant (In case of multicentre clinical studies, submission of approvals for the first clinical site is sufficient.)

Study initiation package – NCL TLHC

Study initiation package-NCL TLHC (before enrolment of the first study participant) including:oRegistration number of the clinical study in a registry meeting WHO Registry criteriaoFinal version of study protocol as approved by the regulator(s) / ethics committee(s)oRegulatory and ethics (if applicable, institutional) approvals required for the enrolment of the first study participant (In case of multicentre clinical studies, submission of approvals for the first clinical site is sufficient.)

Study initiation package – PREVALUNG

Study initiation package- PREVALUNG (before enrolment of the first study participant) including:oRegistration number of the clinical study in a registry meeting WHO Registry criteriaoFinal version of study protocol as approved by the regulator(s) / ethics committee(s)oRegulatory and ethics (if applicable, institutional) approvals required for the enrolment of the first study participant (In case of multicentre clinical studies, submission of approvals for the first clinical site is sufficient.)

Report on the status of posting results in a repository – PREVALUNG ETOILE

Report on the status of posting results in a repository-PREVALUNG ETOILE. Irrespective of the successful completion of the clinical study, summary results must be posted in the applicable registry/ies (where the study was registered) even if the timing of posting of results falls outside of the grant period. The report is to be scheduled for the time results posting is expected or for the last months of the project, whichever comes earlier.

Midterm recruitment report – FLEMENGHO

Midterm recruitment report-FLEMENGHO: This report is due when 50% of the study population is recruited. The report shall include an overview of the number of recruited participants by clinical sites, any problems in recruitment and, if applicable, a detailed description of implemented and planned measures to compensate for any incurred delays.

Report and/or publication on the validity of all four classifiers (CHIP-LC mutations, innate immunity soluble markers, stool TOPOSCORE, ACBP/DBI, polyamines, αketoglutarate (aKG) metabolites) as assessed with primary academic methodologies versus biotech

Report and/or publication on the validity of all four classifiers (CHIP-LCmutations, innate immunity soluble markers, stool TOPOSCORE, ACBP/DBI,polyamines, αketoglutarate (aKG) metabolites) as assessed with primaryacademic methodologies versus biotech devices to predict LC incidence

Websites, patent fillings, videos etc. (1)

Visual identity, website and social media: Project branding, introductory project materials, video, infographics, logo are available, website is published and social media accounts operative

Visual identity, website and social media: Project branding, introductory projectmaterials, video, infographics, logo are available, website is published andsocial media accounts operative

Data sets, microdata, etc (1)

Report on all the available sampling corresponding to lung cancer cases and their relevant paired controls

Publications

Peer reviewed articles (1)

International Journal of Molecular Sciences

Auteurs: Everton Santana; Eliana Ibrahimi; Evangelos Ntalianis; Nicholas Cauwenberghs; Tatiana Kuznetsova
Publié dans: International Journal of Molecular Sciences, Numéro 25, 2024, ISSN 1422-0067
Éditeur: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/IJMS252312905

Conference proceedings (2)

EP.04C.04 Extended Inclusion Criteria for Lung Cancer Screening to Tabacco Related Diseases: Comparison of Preliminary Results in Two Prospective Cohorts

Auteurs: E. Armand, P. Habert, P.-A. Thomas, X.-B. D'journo, C. Doddoli, A. Fourdrain, D. Trousse, G. Brioude, H. Dutau, I. Hamouda, L. Greillier, A. Mogenet, A. Todesco, J. Tronchetti, J.-B. Lovato, J. Pluvy, O. Mercier, J. Issard, C. Caramella, P. Pradere, D. Boulate
Publié dans: Journal of Thoracic Oncology, Numéro 19, 2025, ISSN 1556-0864
Éditeur: Elsevier BV
DOI: 10.1016/J.JTHO.2024.09.866

1510 Multiomic functional biomarkers for cancer prediction and early detection

Auteurs: Marine Fidelle, Deborah Suissa, Roxanne Birebent, et al
Publié dans: Journal for immunotherapy of cancer, Numéro 11, 2023, ISSN 2051-1426
Éditeur: BMJ Publishing Group Ltd & Society for Immunotherapy of Cancer
DOI: 10.1136/jitc-2023-SITC2023.1510

Other (1)

Bile acids regulate MAdCAM-1 expression to link the gut microbiota to cancer immunosurveillance

Auteurs: Marine Fidelle, Ai-Ling Tian, Laurence Zitvogel, Guido Kroemer
Publié dans: Oncoimmunology, Numéro 12, 2023
Éditeur: Taylor & Francis Group
DOI: 10.1080/2162402X.2023.2224672