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出境医 / 临床实验 / IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE (i-BANK)
IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE (i-BANK)
Study Description
Brief Summary:
Interventional study of a group of patients with an inflammatory bowel disease (Crohn's disease or ulcerative colitis) to identify predictive and prognostic biomarkers of natural history and response to biotherapies.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis | Procedure: endoscopic biopsy Procedure: samples of the oral cavity Procedure: Samples of the resected specimen | Not Applicable |
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).
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1000 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS OF NATURAL HISTORY AND RESPONSE TO BIOTHERAPIES IN INFLAMMATORY BOWEL DISEASE : i-BANK |
| Estimated Study Start Date : | April 2, 2019 |
| Estimated Primary Completion Date : | April 2, 2021 |
| Estimated Study Completion Date : | April 2, 2029 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
IBD patients
All patients with an established Crohn's disease or ulcerative colitis
|
Procedure: endoscopic biopsy
Per-endoscopic biopsies
Procedure: samples of the oral cavity 7 samples of the oral cavity with a swab
Procedure: Samples of the resected specimen 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 Outcome Measures :
- Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab). [ Time Frame: 5 years ]
Secondary Outcome Measures :
- Proportion of patients who underwent surgery [ Time Frame: 5 years ]
- Post-operative morbidity rates in IBD [ Time Frame: 5 years ]
- Surgical recurrent rate in Crohn's disease [ Time Frame: 5 years ]
- Propotion of patients with a destruction of the intestinal wall in CD (abscess, fistula) [ Time Frame: 5 years ]
- Proportion of patients developing a cancer [ Time Frame: 5 years ]
- Readmission rates for acute severe colitis or ileitis [ Time Frame: 5 years ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
Contacts
| Contact: Adeline GERMAIN, MD, PhD | +33383153120 | a.germain@chru-nancy.fr |
Locations
| France | |
| CHRU Nancy | |
| Vandœuvre-lès-Nancy, France, 54510 | |
| Contact: Marjorie STARCK +33383155273 m.starck@chru-nancy.fr | |
| Sub-Investigator: Laurent PEYRIN-BIROULET, MD, PhD | |
| Principal Investigator: Adeline GERMAIN, MD,PhD | |
| Sub-Investigator: Laurent BRESLER, MD | |
| Sub-Investigator: Camille ZALLOT, MD | |
| Sub-Investigator: Marine FERRY, MD | |
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
| Principal Investigator: | Adeline GERMAIN, MD, PhD | CHRU Nancy |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | January 17, 2019 | ||||
| First Posted Date ICMJE | January 18, 2019 | ||||
| Last Update Posted Date | January 18, 2019 | ||||
| Estimated Study Start Date ICMJE | April 2, 2019 | ||||
| Estimated Primary Completion Date | April 2, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab). [ Time Frame: 5 years ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE | ||||
| Official Title ICMJE | IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS OF NATURAL HISTORY AND RESPONSE TO BIOTHERAPIES IN INFLAMMATORY BOWEL DISEASE : i-BANK | ||||
| Brief Summary | Interventional study of a group of patients with an inflammatory bowel disease (Crohn's disease or ulcerative colitis) to identify predictive and prognostic biomarkers of natural history and response to biotherapies. | ||||
| 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). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
|
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| Intervention ICMJE |
|
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| Study Arms ICMJE | IBD patients
All patients with an established Crohn's disease or ulcerative colitis
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE |
1000 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | April 2, 2029 | ||||
| Estimated Primary Completion Date | April 2, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03809728 | ||||
| Other Study ID Numbers ICMJE | PSS 2018 / I-BANK-GERMAIN / MS | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Central Hospital, Nancy, France | ||||
| Study Sponsor ICMJE | Central Hospital, Nancy, France | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Central Hospital, Nancy, France | ||||
| Verification Date | January 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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