Ileal Crohn's Disease and Post-operative Outcome: Prospective Cohort Study of the REMIND Group (POP-REMIND)
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|ClinicalTrials.gov Identifier: NCT03458195|
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : March 17, 2021
Crohn's disease (CD), a chronic inflammatory process in intestinal segments leads to tissue damage. More than two thirds of CD patients need intestinal resection. Symptomatic clinical recurrence occurs in 60% by 10 years. The principal factors affecting postoperative recurrence are active smoking, penetrating disease, perianal lesions history, prior intestinal resection, small bowel resection extent, and prophylaxis treatment absence.
Ileocolonoscopy within one year of surgery can predict clinical recurrence risk.
Different therapies are proposed after surgery, to prevent post-operative recurrence : Thiopurines, 6-mercaptopurine (positive for clinical and endoscopic postoperative recurrence prevention), Anti-tumour necrosis factor therapy (anti-TNF), the most effective therapy.
Intestinal microbiota acts as a central factor in the CD pathogenesis, and fecal stream role is clearly shown. Various changes in luminal flora with a possible link to local inflammation was also demonstrated. Bacteria associated with postoperative recurrence could be more pathogenic as adherent invasive E coli (AIEC), which could be a pathogen in CD through several mechanisms including increased mucosal colonization, adherence, replication and induction of TNF secretion. Alternatively, postoperative CD recurrence could be linked to a protective commensal species lack, such as Faecalibacterium prausnitzii.
Microscopic inflammation occurs as early as 8 days after anastomosis in the neoterminal ileum mucosa. IL6, IL10 and TGFb levels, measured in neoterminal ileum early after surgery are associated with different rates of postoperative recurrence. It suggests cytokines implication in postoperative recurrence. T cells are major players in the intestinal immune response. The presence at time of surgery and persistence of disease inducing T cell clonal expansions could play an important role in post-operative recurrence.
The main objective is to define a classification of ileal Crohn's Disease based on data integration on a large cohort of patients.
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Other: bio-banking collection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||575 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients aged 18 or more, for whom Crohn's disease diagnosis is confirmed and ileum or ileocecal Crohn's disease require surgical resection. in addition to usual practice, a bio-banking (blood samples, biopsies and surgical specimens) is collected.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Ileal Crohn's Disease and Post-operative Outcome: Prospective Cohort Study of the REMIND Group|
|Actual Study Start Date :||December 10, 2009|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2026|
Experimental: Crohn's disease patients
Patients aged 18 or more, for whom Crohn's disease diagnosis is confirmed and ileum or ileocecal Crohn's disease require surgical resection. in addition to usual practice, a bio-banking (blood samples, biopsies and surgical specimens) is collected.
Other: bio-banking collection
blood samples, biopsies, and surgical specimen collected in addition to usual practice
- Ileal Crohn's disease classification [ Time Frame: surgery time, Time 0 ]Ileal Crohn's disease classification will be performed using data integration (taking into account clinical data, immunological, genetic, microbiota, transcriptome data). A molecular classification will be possible due to this data integration analysis
- Postoperative recurrence study [ Time Frame: 6 months after surgery ]Rates of endoscopic recurrence as defined by a Rutgeerts score ≥ 1 in patients will be evaluated at the endoscopic exam
- Study of Treatments efficacy to prevent recurrence [ Time Frame: 6 months after surgery time ]During a clinical visit, scheduled as usual practice 6 months after surgery, clinical data will be collected : treatment modification or optimization, recurrence occurrence. If treament modification or optimization is needed (clinical symptoms or endoscopic recurrence), or complication occurs (abcess, occlusive syndrom, new surgery), patient will be considered as suffering a long-term relapse
- Identification of biomarkers which could predict postoperative recurrence and response to treatments [ Time Frame: surgery time, Time 0 ]Identification of biomarkers taking into account clinical data, immunological, genetic, microbiota, transcriptome data
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458195
|Contact: Matthieu ALLEZ, Pr||+33(1) 42 49 95 75||Matthieu.email@example.com|
|Contact: Philippe SEKSIK, Pr||+33(1) 49 28 31 62||Philippe.firstname.lastname@example.org|
|Principal Investigator:||Matthieu ALLEZ, Pr||Remind|