Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ileal Crohn's Disease and Post-operative Outcome: Prospective Cohort Study of the REMIND Group (POP-REMIND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03458195
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Madeleine Bezault, Saint-Louis Hospital, Paris, France

Brief Summary:

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

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 575 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent obtained before any study-related activities
  • A diagnosis of CD, based on clinical, radiologic, endoscopic, or histological evidence.
  • Men and women ≥18 years of age
  • Required surgical intervention consisting in an ileocecal resection

Exclusion Criteria:

  • Previous history of dysplasia or cancer in the ileum or colon
  • Unwillingness or inability to follow the procedures outlined in the protocol
  • Pregnant women

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Matthieu ALLEZ, Pr +33(1) 42 49 95 75 Matthieu.allez@aphp.fr
Contact: Philippe SEKSIK, Pr +33(1) 49 28 31 62 Philippe.seksik@aphp.fr

Locations
Show Show 17 study locations
Sponsors and Collaborators
Saint-Louis Hospital, Paris, France
Investigators
Layout table for investigator information
Principal Investigator: Matthieu ALLEZ, Pr Remind
Publications of Results:

Other Publications:
Layout table for additonal information
Responsible Party: Madeleine Bezault, Pr Matthieu Allez, Saint-Louis Hospital, Paris, France
ClinicalTrials.gov Identifier: NCT03458195    
Other Study ID Numbers: POP STUDY - REMIND
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Madeleine Bezault, Saint-Louis Hospital, Paris, France:
ileo-caecal resection; post-operative recurrence
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases