Since IBD National Study Groups often come up with solid clinical research questions but face problems with recruiting a decent number of patients, the Clinical Research Committee of ECCO (ClinCom) decided to organise a meeting for representatives of European IBD National Study Groups to meet and to exchange views on study projects. The 1st edition of the IBD National Study Group meeting took place at the ECCO Congress 2016 Amsterdam, with the clear aim to support the collaboration among study groups. Following the successful experience, the IBD National Study Group meeting now takes place on a yearly basis, at the ECCO Congress.
Prior to the meeting, a call for study proposals is sent to the IBD Community, to give investigators the opportunity to present their study projects directly to representatives of IBD National Study Groups, to challenge their ideas and foster interest. Each protocol received goes through a free and thorough assessment in two stages (see details in section “Review of Study Protocol: A Two-Stage Process).
Which kind of studies are presented at the IBD National Study Group meeting?
Review of study protocol: A two-stage process
The assessment of a clinical research protocol encompasses a two-stage process. During the first stage, applicants are called upon to provide a study synopsis including background, design, objectives, outcome parameters, major inclusion and exclusion criteria, statistics, and co-variates not exceeding 4 pages. The first stage’s template is sent by the ECCO Office to the interested submitters upon request, once the call is issued.
Once this first stage application is submitted, the project is reviewed by ClinCom who decides to either support or decline the presentation at the National Study Group Meeting. After the meeting, the PI is invited to submit a full protocol (2nd stage) taking into account the feedback given during the IBD National Study Group meeting. A 2nd stage template is sent by the ECCO Office to the PI.
After the review and approval of the 2nd stage protocol by ClinCom and by the ECCO Governing Board, ECCO offers to support the dissemination of a call to participate to the study project among the IBD Community, to support the recruitment of centres. ECCO does not provide any financial or logistical support to studies. The review by ClinCom of a study protocol is not an ECCO endorsement to the project. It is not allowed to use ECCO’s name and logo to promote a study. ClinCom’s support should be acknowledged in any publication.
Should you have any questions, please contact the ECCO Office (This email address is being protected from spambots. You need JavaScript enabled to view it.)
Project leaders: |
João A. Cunha Neves, MD*; Joana Roseira, MD, PhD student*; Helena Tavares de Sousa, MD, PhD student* |
Purpose and outcome: |
Rational: Vedolizumab and ustekinumab are considered the top-tier safest biologic medications for inflammatory bowel disease (IBD). Both these drugs are important therapeutic options in a particular pool of patients not suitable to anti-TNFα drugs, namely those with present or previous malignancies and elderly. Once vedolizumab failure is established, most patients will be offered ustekinumab therapy, and robust evidence on efficacy and safety of this second-line treatment regimen in this setting is lacking. Research hypothesis: Primary objective: To assess clinical remission of ustekinumab as second-line treatment after failure of vedolizumab in anti-TNFα naïve patients. Secondary objectives: |
Deadline to participate: | May 31, 2023 |
Target group: |
Every IBD centre with a retrospective database or list of adult IBD patients, with easily retrievable data and a low risk of missed cases, who are willing to provide information about their patients. |
Link to the invitation letter | Invitation Letter |
Project leaders: |
Prof. Gianluca Pellino, Dr. Alice Gori, Prof. Matteo Rottoli, Mr. Valerio Celentano , Salvatore Leone , Prof. Antonino Spinelli, Prof. Giuseppe S. Sica, Prof. Gianluca Sampietro, Prof. Francesco Selvaggi |
Purpose and outcome: |
Purpose Outcome measures
Secondary endpoints:
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Deadline to participate: | March 31, 2023 |
Target group: |
Colorectal surgery centers from any country with high IBD incidence (>/= 50 patients in the study period) will be eligible for the study. Each center will create a work team composed by: 1 Hospital lead/Principal Investigator, 3 collaborators, 1 data validator. Inclusion criteria
Exclusion criteria
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Link to the invitation letter | Invitation Letter |
Project leaders: |
Department of medical sciences, University of Turin, Turin, Italy. Internal medicine, Department of internal medicine, IRCCS San Matteo Hospital Foundation, University of Pavia, Pavia, Italy |
Purpose and outcome: |
The main objective of this study is the evaluation of the incidence rate of colitis remission basing on the CTCAE scale within 12 months.
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Deadline to participate: | October 31, 2022 |
Target group: |
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Link to the invitation letter | Invitation Letter |
Project leaders: |
Pancreas Institute, University of Verona, Italy |
Purpose and outcome: |
The primary aim of the study is to evaluate the prevalence of AP in IBD patients. Secondary aims include:
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Deadline to participate: | September 14, 2022 |
Target group: |
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Link to the invitation letter | Invitation Letter |
Project leaders: |
Careggi University Hospital, Firenze, Italy |
Purpose and outcome: |
The aim of this study would be to determine the safety of TOFA administration in the weeks before total colectomy for medically refractory UC. In addition, a subsequent analysis on potential predictive factors of adverse outcomes within TOFA group of treatment might provide precious information on safe patient selection. |
Deadline to participate: | September 15, 2022 |
Target group: |
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Link to the invitation letter | Invitation Letter |
Project leaders: |
IBD unit of the University Hospital Ghent |
Purpose and outcome: | The aim of this study is to compare the incidence of ePOR at short term in CD patients after ileocecal resection with two different strategies: prophylactic early postoperative initiation of medical treatment (“pro-active approach”) vs. treatment driven by postoperative endoscopic findings (“reactive approach”). |
Deadline to participate: | June 30, 2021 |
Target group: |
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Project leaders: |
NIHR Global Health Research Unit on Global Surgery |
Purpose and outcome: |
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Deadline to participate: | October 2020 |
Target group: |
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Project leaders: |
IBD center at Rabin Medical Center (Petah-Tikva, Israel) |
Purpose and outcome: | A multicenter retrospective cohort study to assess the efficacy of either vedolizumab or ustekinumab (cases) compared with anti-TNFs (controls) for the prevention of CD recurrence after a curative ileocecal resection. |
Results: | Submission of an abstract to ECCO'21 and a full manuscript thereafter |
Project leaders: |
Belgian IBD Research and Development group (BIRD) |
Purpose and outcome: | • To study the efficacy and safety of combining biological treatments together, or with new small molecules in IBD and IMID. • To identify subgroups of patients who may present safety issues either due to the drugs combinations or patient characteristics itself (age, comorbidities, previous medical history etc.) • To study the outcome on extra-intestinal manifestations if any. • To study the effect of the combination treatment on IBD and IMID disease activity. |
Results: | Submission of an abstract to ECCO'21 and a full manuscript thereafter |
Project leaders: |
Sheba Medical Center (Ramat Gan, Israel) | |
Purpose and outcome: | In patients losing response to ustekinumab, possible therapeutic options may include shortening of interval between doses and intravenous reinduction. However, there is very little evidence to support the effectiveness of dose-optimisation strategy to manage primary or secondary non-response to ustekinumab. Thus, we are proposing a wide collaborative retrospective study to evaluate the effectiveness of dose escalation strategy with usekinumab in CD. | |
Publications: |
Full manuscript: Effectiveness of ustekinumab dose escalation in Crohn’s disease patients with insufficient response to standard‐dose subcutaneous maintenance therapy. Kopylov U, Hanzel J, Liefferinckx C, De Marco D, Imperatore N, Plevris N, Baston‐Rey I, Harris RJ, Truyens M, Domislovic V, Vavricka S, Biemans V, Myers S, Sebastian S, Ben‐Horin S, González Lama Y, Gilletta C, Shitrit Ariella B-G, Zelinkova Z, Weishof R, Storan D, Zittan E, Farkas K, Molnar T, Franchimont D, Cremer A, Afif W, Castiglione F, Lees C, Barreiro‐de Acosta M, Lobaton T, Doherty G, Krznaric Z, Pierik M, Hoentjen F, Drobne D. AP&T https://doi.org/10.1111/apt.15784 |
Project leaders: |
University Hospitals of Leuven (Belgium), the Erasmus MC (Rotterdam, The Netherlands), the Shaare Zedek Medical Center (Jerusalem, Israel) | |
Purpose and outcome: | Very few data are available regarding pregnancy outcomes in female patients with IBD treated with vedolizumab. Expanding the existing study initiatives to a European level would certainly provide more data on the safety of vedolizumab in pregnancy and offspring. European research groups and individual IBD centers are invited to collaborate on this topic in a retrospective, multi-center cohort study. | |
Publications: | Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti-TNF or conventional therapy: results of the European CONCEIVE study. Moens A, van der Woude CJ, Julsgaard M, Humblet E, Sheridan J, Baumgart DC, Gilletta De Saint-Joseph C, Nancey S, Rahier JF, Bossuyt P, Cremer A, Dewit S, Eriksson C, Hoentjen F, Krause T, Louis E, Macken E, Milenkovic Z, Nijs J, Posen A, Van Hootegem A, Van Moerkercke W, Vermeire S, Bar-Gil Shitrit A, Ferrante M. Aliment Pharmacol Ther. 2019 Nov 6. doi: 10.1111/apt.15539 |