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NCT Number: NCT03809728

IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE

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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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Nancy

Vandœuvre-lès-Nancy, 54510, France

Location status: Recruiting

Location contact

Adeline GERMAIN, MD,PhD

PRINCIPAL_INVESTIGATOR

Camille ZALLOT, MD

SUB_INVESTIGATOR

Laurent BRESLER, MD

SUB_INVESTIGATOR

Laurent PEYRIN-BIROULET, MD, PhD

SUB_INVESTIGATOR

Marine BECK

CONTACT

[email protected]

+33383155280

Marine FERRY, MD

SUB_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

  1. Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab).

    Time frame: 5 years

Secondary outcomes

  1. Proportion of patients who underwent surgery

    Time frame: 5 years

  2. Post-operative morbidity rates in IBD

    Time frame: 5 years

  3. Surgical recurrent rate in Crohn's disease

    Time frame: 5 years

  4. Proportion of patients with a destruction of the intestinal wall in CD (abscess, fistula)

    Time frame: 5 years

  5. Proportion of patients developing a cancer

    Time frame: 5 years

  6. Readmission rates for acute severe colitis or ileitis

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Adeline GERMAIN, MD, PhD

CONTACT

[email protected]

+33383153120

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: i-BANK

Important dates

Study start
2019
Primary completion
2034
Study completion
2034
First posted
Jan 18, 2019
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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