DNA methylation markers to predict treatment success of biologicals in Crohn’s disease.

Project Information

METHYLOMIC

Grant agreement ID: 101095449

DOI

10.3030/101095449

EC signature date 24 November 2022

Start date 1 January 2023

End date 31 December 2026

Funded under

• Health

Total cost

€ 9 376 995,25

EU contribution

€ 9 376 995,25

Coordinated by

STICHTING AMSTERDAM UMC
Netherlands

CORDIS provides links to public deliverables and publications of HORIZON projects.

Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .

Deliverables

Documents, reports (19)

Updated Data Management Plan

Updated data management plan.

Midterm recruitment report EPISORA trial

Midterm recruitment report of WP4

Data management plan (DMP)
Study protocols and informed consent templates as part of the clinical study submission package
All approvals package EPISORA trial

Package with regulatory approvals of all clinical sites

Log of all communication activities performed till midterm

Log of all communication activities performed during the first half of the project

Plan for dissemination and exploitation
Single-cell transcriptome and DNA methylome profiles of PBL obtained from healthy individuals

Single-cell transcriptome and DNA methylome profiles of PBL obtained from healthy individuals (npatients = 10; ncells = 1.000)

METHYLOMIC data monitoring manual
Submission package OMICROHN trial

A submission package, prior to enrollment of first subject, containing the final version of the study protocol as submitted to regulators, a registration number of the trial in a WHO or ICMJE-approved registry and approval from ethics committees and national competent authorities if applicable, prior to enrollment of first subject in at least one clinical centre

Clinical trial agreement and informed consent templates
Submission package EPISORA trial

A submission package, prior to enrollment of first subject, containing the final version of the study protocol as submitted to regulators, a registration number of the trial in a WHO or ICMJE-approved registry and approval from ethics committees and national competent authorities if applicable, prior to enrollment of first subject in at least one clinical centre

Terms of Reference of the established DEIPC and PAC
All approvals package OMICROHN trial

Package with regulatory approvals of all 54 clinical sites

Educational training programme for all scientists
Optimised protocols and workflow available for Smart-RRBS
Protocols for use of the assay for CD patient selection in WP3
Defined set of criteria for market authorisation of the assay for RA and PsO
Defined set of criteria for market authorisation of the assay for CD

Websites, patent fillings, videos etc. (3)

Podcast series
Documentary film

Documentary film that displays the opposing perspectives and those in favour of predictive biomarkers for IBD treatment stratification

Project website and social media channels

Project website and social media channels including a detailed social media strategy for online presence of the project and consortium

Publications

Peer reviewed articles (1)

Development and validation of peripheral blood DNA methylation signatures to predict response to biological therapy in adults with Crohn's disease (EPIC-CD): an epigenome-wide association study

Author(s): Vincent W Joustra, Andrew Y F Li Yim, Peter Henneman, Ishtu Hageman, Tristan de Waard, Evgeni Levin, Alexandra J Noble, Thomas P Chapman, Femke Mol, Sarah van Zon, Donghyeok Lee, Colleen G C McGregor, Melanie S Hulshoff, Jack J Satsangi, Wouter J de Jonge, Geert R D'Haens, Hans Paulich, Inge van Welsen, Rishand K. Ramkisoen, Yara E. Abeling, Marloes Zwart, Nicole E.M. Berkers, Caroline Verseijden, Anje A. te Velde, Nicola Radcliffe, Aisling Quinn, Beatriz Camesella Perez, Tom Thomas, Rahul Ravindran, James Chivenga, Simon Travis
Published in: The Lancet Gastroenterology & Hepatology, Issue 10, 2025, ISSN 2468-1253
Publisher: Elsevier BV
DOI: 10.1016/S2468-1253(25)00102-5