CORDIS oferuje możliwość skorzystania z odnośników do publicznie dostępnych publikacji i rezultatów projektów realizowanych w ramach programów ramowych HORYZONT.
Odnośniki do rezultatów i publikacji związanych z poszczególnymi projektami 7PR, a także odnośniki do niektórych konkretnych kategorii wyników, takich jak zbiory danych i oprogramowanie, są dynamicznie pobierane z systemu OpenAIRE .
Rezultaty
TASK 9.3 –Translating Recommendations regarding the use Treatment Cycles into Guidelines [M82-M93] [IBDIM]Provisional guideline statements generated by integrating Factors, Score Values [Task 9.1] and measures to increase readiness [Tasks 9.2] will be the basis for establishing the Guidelines. Guidelines will be established under the leadership of IBDIM in compliance with the regular Consensus procedure already previously used to promote a European perspective on the management of CD and its dilemmas. One consensus meeting will be organized in 2022 to agree on the provisional guideline statements with 20 participants not included in the BIOCYCLE Project. The consensus procedures, as in previous cases of Guidelines building, will include revising the provisional statements until a consensus will be reached. Consensus will be defined as agreement >80% of participants according to clearly established voting rules [for details on the procedure, please refer to Part-B, section 4, page 46]. Statements with more than 80% of agreement are accepted as final consensus statements.The final Guidelines will be written by the BIOCYCLE experts including 1 representative of either ECCO SciCom or ClinCom under the leadership of IBDIM. The final publication will explain the full process by which Consensus was obtained and the methods used to propose the statements.Between M82 and M93, in collaboration with WP2 in charge of dissemination of the guidelines and training as well as of the collection of the feedbacks, namely from trainees, improvements of the guidelines will be further performed prior to their presentation at the ECCO congress 2023.
Final version of study protocol as submitted to regulators ethics committeesno need to change deliverable if later amendmentsRegistration number of clinical study in a WHO or ICMJE approved registryPlease note Result posting for the study must be possibleApprovals ethics committees and national competent authority if applicable required for invitation enrolment of first subject in at least one clinical centre
Final SPARE Clinical Study report (odnośnik otworzy się w nowym oknie)Idem delivrable D358 Final study report Dec 2022 M93Delivrable D35Description of workThe study conduct is fully and extensively described in the document entitled Essential information regarding the SPARE clinical study Briefly the trial is a multicenter randomized three arms openlabeled trial in Crohns disease in stable remission under infliximabantimetabolites Combo therapy comparing infliximabantimetabolites continuation vs infliximab discontinuation vs antimetabolites discontinuationThe study will be performed in 7 countries France UK Belgium Sweden Germany The Netherlands and Australia according to a cosponsorship organisation the GETAID in France being the main sponsor and CHU UEDIN RSSUH Charit AMC and MELBOURNE being the cosponsors 200220 patients will be recruited in 6080 centresAll the data of the clinical trial will be collected through a unique centralized eCRF which will be developed in collaboration with INSERM who will be responsible of the data management WP7 and statistical analysis WP8The preparatory phase prior to the first investigators meeting will be ready by the start of the BIOCYCLE Project 042015 All authorizations for performing the study in the 7 countries will be obtained on the latest in Q42014 already obtained in BE and FR CRF will be approved The clinical study team will also be completed as well as the clinical sites identification and contracts Thus between April 2015 Study Start and March 2021 Study End the main steps and milestones are1 Investigator meeting April 2015 M12First patient screened April 2015 M13Last patient screened March 2019 M484 Last patient complete March 2021 M725 Database lock Oct 2021 M796 Statistical analysis WP7 and WP8 Nov 2021 M807 Draft report available Mar 2022 M84Each clinical site will also perform biological samples collection and local storage by following the protocols summarized in EXHIBIT 8 of the Essential information regarding the SPARE clinical study The samples will be ready to be transferred to the central Biobank for biomarkers analyses according to WP4 tasks description
The BIOCYCLE website will be the firstlevel information center on the general progress of the project sCINNAMIC will be in charge of designing and updating the website which will give separate access to patients associations the medical community and other stakeholders eg policymakers needing information to better understand the objectives of the Project and how their achievement may have an impact on their own activities decisions and orientation The BIOCYCLE website will act as the firstlevel interface between the BIOCYCLE consortium and the outside world for collecting and sorting questions redirecting specific queries to the right members of the consortium and as such to measure the interest of the public and stakeholders for this projectThe website will also regularly post eg short newsletters on major advances of the BIOCYCLE Project publications prepared during the Project and short tutorialsA secured access to the Participants will include templates monitoring and reporting procedures for scientific and financial reporting summaries on crossdisciplinary discussions used definitions meeting notes access to general documentation
Publikacje
Autorzy:
E Louis J, M Resche-Rigon, D Laharie, J Satsangi, N Ding, J Preiss, G D’Haens, L Picon, P Bossuyt, L Vuitton, P Irving, Y Bouhnik, S Viennot, C Lamb, R Pollock, F Baert, M Nachury, F Mathurin, C Gilletta, J F Colombel, E Hertervig
Opublikowane w:
Journal of Crohn's and Colitis, Numer 16(1), 2022, Strona(/y) Page i001, ISSN 1873-9946
Wydawca:
Elsevier Science
DOI:
10.1093/ecco-jcc/jjab232.000
Autorzy:
Nurulamin M Noor, Paula Sousa, Dominik Bettenworth, Fernando Gomollón, Triana Lobaton, Peter Bossuyt, Maria Jose Casanova, Nik S Ding, Gabriele Dragoni, Federica Furfaro, Patrick F van Rheenen, Maria Chaparro, Javier P Gisbert, Edouard Louis, Konstantinos Papamichail
Opublikowane w:
Journal of Crohn's and Colitis, Numer 17(7), 2023, Strona(/y) Pages 1031–1045, ISSN 1873-9946
Wydawca:
Elsevier Science
DOI:
10.1093/ecco-jcc/jjad001
Autorzy:
Prof Edouard Louis, MD
Prof Matthieu Resche-Rigon, MD *
Prof David Laharie, MD *
Prof Jack Satsangi, DPhil *
Nik Ding, MBBS PhD
Prof Britta Siegmund, MD
Prof Geert D'Haens, MD
Laurence Picon, MD
Peter Bossuyt, MD
Prof Lucine Vuitton, MD
Peter Irving, MD
Stephanie Viennot, MD
Christopher A Lamb, MBBS PhD
Richard Pollok, MD
Filip Baert, MD
Maria Nachury, MD
Prof Mathurin Fumery, MD
Cyrielle Gillett
Opublikowane w:
Lancet Gastroenterology & Hepatology, Numer 8(3), 2023, Strona(/y) 215-227, ISSN 0140-6736
Wydawca:
The Lancet Publishing Group
DOI:
10.1016/s2468-1253(22)00385-5
Autorzy:
Thomas P Chapman, Catarina Frias Gomes, Edouard Louis, Jean-Frédéric Colombel, Jack Satsangi
Opublikowane w:
The Lancet Gastroenterology & Hepatology, Numer 5/1, 2020, Strona(/y) 63-79, ISSN 2468-1253
Wydawca:
The Lancet
DOI:
10.1016/s2468-1253(19)30186-4
Autorzy:
Joana Torres, Ray K. Boyapati, Nicholas A. Kennedy, Edouard Louis, Jean-Frédéric Colombel, Jack Satsangi
Opublikowane w:
Gastroenterology, Numer 149/7, 2015, Strona(/y) 1716-1730, ISSN 0016-5085
Wydawca:
W. B. Saunders Co., Ltd.
DOI:
10.1053/j.gastro.2015.08.055
Autorzy:
Jack Satsangi, Olivier Kitten, Marcela Chavez, Rahul Kalla, Nadege Prel, Marie-Alice Meuwis, Stephanie Scott, Illaria Bonetti, Nicholas T. Ventham, Edouard Louis
Opublikowane w:
Journal of Crohn's and Colitis, Numer 10/3, 2016, Strona(/y) 363-370, ISSN 1873-9946
Wydawca:
Elsevier Science
DOI:
10.1093/ecco-jcc/jjv237
Autorzy:
Edouard Louis
Opublikowane w:
Inflammatory Bowel Diseases, Numer 24(4), 2018, Strona(/y) 725-731, ISSN 1078-0998
Wydawca:
Lippincott Williams & Wilkins Ltd.
DOI:
10.1093/ibd/izx098
Autorzy:
Nathalie Y Pauwen, Edouard Louis, Corey Siegel, Jean-Frederic Colombel, Jean Macq
Opublikowane w:
Journal of Crohn's and Colitis, Numer 12/12, 2018, Strona(/y) 1499-1504, ISSN 1873-9946
Wydawca:
Elsevier Science
DOI:
10.1093/ecco-jcc/jjy128
Autorzy:
Edouard Louis
Opublikowane w:
Frontiers in Medicine, Numer 6, 2020, ISSN 2296-858X
Wydawca:
Frontiers in Medicine
DOI:
10.3389/fmed.2019.00302
Autorzy:
Corey A. Siegel, Kimberly D. Thompson, Danielle Walls, Jan Gollins, Anne Buisson, Alain Olympie, Laurent Beaugerie, Jean-Frederic Colombel, Edouard Louis
Opublikowane w:
Clinical Gastroenterology and Hepatology, Numer 19(2), 2019, Strona(/y) 403-405, ISSN 1542-3565
Wydawca:
W. B. Saunders Co., Ltd.
DOI:
10.1016/j.cgh.2019.11.062
Autorzy:
Kristian Bolin, Erik Hertervig, Edouard Louis
Opublikowane w:
Journal of Crohn's and Colitis, Numer 13/10, 2019, Strona(/y) 1323-1333, ISSN 1873-9946
Wydawca:
Elsevier Science
DOI:
10.1093/ecco-jcc/jjz063
Autorzy:
D Radford-Smith, J Satsangi, E Louis, D Laharie, N Ding, B Siegmund, G D’Haens, H Erik, A Yates, D Anthony, J F Colombel, F Probert GETAID and the SPARE-Biocycle research group
Opublikowane w:
Journal of Crohn's and Colitis, Numer 16(1), 2022, Strona(/y) i458-i460
Wydawca:
Oxford Academic
DOI:
10.1093/ecco-jcc/jjab232.621
Autorzy:
N Pierre, V A Huynh-Thu, D Baiwir, G Mazzucchelli, M Fléron, L Trzpiot, G Eppe, D Laharie, J Satsangi, J F Colombel, E Hertervig, M A Meuwis, E Louis, GETAID and the SPARE-Biocycle research group
Opublikowane w:
Journal of Crohn's and Colitis, Numer 17(1), 2023, Strona(/y) i3-i6
Wydawca:
Oxoford Academic
DOI:
10.1093/ecco-jcc/jjac190.0002
Autorzy:
NICOLAS PIERRE, ECCO MEMBER
Opublikowane w:
ECCO News 2021, Numer 16(3), 2021
Wydawca:
ECCO
Autorzy:
Edouard Louis
Opublikowane w:
Inflamm Intest Dis, Numer 7 (1), 2022, Strona(/y) 64–68, ISSN 2296-9365
Wydawca:
Karger
DOI:
10.1159/000520942
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