IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE

NCT03809728 — Not applicable, Recruiting, 1000 participants, Central Hospital, Nancy, France

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IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS OF NATURAL HISTORY AND RESPONSE TO BIOTHERAPIES IN INFLAMMATORY BOWEL DISEASE : i-BANK

Registry	NCT03809728, acronym i-BANK
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	1000 (Estimated)
Sponsor	Central Hospital, Nancy, France (Other)
Conditions	Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
Interventions	endoscopic biopsy, samples of the oral cavity, Samples of the resected specimen (Procedure)
Dates	start 2019-12-10, primary completion 2034-12-10 (estimated), completion 2034-12-10 (estimated), first posted 2019-01-18, last updated 2024-02-07
Locations	1 site in France

-Summary

Interventional study of a group of patients with an inflammatory bowel disease (IBD; Crohn's disease (CD) or ulcerative colitis (UC)) to identify predictive and prognostic biomarkers of natural history and response to biotherapies.

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+Detailed description

Percentage of primary responders who haven't lost response to biotherapies during follow-up (anti-TNF, ustekinumab, vedolizumab).

Response to treatment will be evaluated using objective criteria for measuring intestinal inflammation: endoscopic remission (endoscopic biopsy and surgical specimens), radiological (MRI), and / or biological (CRP, fecal calprotectin) .

Response to therapy rates will be correlated with genomic, epigenomic, and microbiota data stratified by major environmental factors (nutrition, tobacco, physical activity).

+Arms and interventions

Arm	Type	Interventions	Description
IBD patients	Other	Procedure: endoscopic biopsy; Procedure: samples of the oral cavity; Procedure: Samples of the resected specimen	All patients with an established Crohn's disease or ulcerative colitis

endoscopic biopsy (Procedure): Per-endoscopic biopsies
samples of the oral cavity (Procedure): 7 samples of the oral cavity with a swab
Samples of the resected specimen (Procedure): if patient has to undergo a digestive resection as part of his standard management, samples of the pathological area and samples at the end of the resection will be realised

+Outcome measures

Primary outcomes

Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab). [5 years]

Secondary outcomes

Proportion of patients who underwent surgery [5 years]
Post-operative morbidity rates in IBD [5 years]
Surgical recurrent rate in Crohn's disease [5 years]
Proportion of patients with a destruction of the intestinal wall in CD (abscess, fistula) [5 years]
Proportion of patients developing a cancer [5 years]
Readmission rates for acute severe colitis or ileitis [5 years]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Age>=18 years
* Patients with an established diagnosis of CD or UC (clinical, biological, radiological, endoscopic or histologic criteria)
* Patients >=45 kg
* Affiliated member of the Social Security system

Exclusion Criteria:

* Patients with an undetermined colitis
* Patients with a non established diagnosis of CD
* Women of childbearing age without a method of contraception
* Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code
* Pregnant women, breastfeeding women

  \-- Age < 18 years
* Persons under legal protection
* Person who does not have the capacity to consent
* Persons under the age of 18 years who are deprived of their liberty by decision of a judicial or administrative authority (articles L. 3212-1 and L. 3213-1).

+Locations (1)

Facility	City	Country	Status
CHRU Nancy	Vandœuvre-lès-Nancy	France	Recruiting

+Investigators

Adeline GERMAIN, MD, PhD, Principal investigator, CHRU Nancy

My Notes

Public

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