Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBD patients | Other | All patients with an established Crohn's disease or ulcerative colitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic biopsy | Procedure | Per-endoscopic biopsies |
| |
| samples of the oral cavity |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab). | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who underwent surgery | 5 years | |
| Post-operative morbidity rates in IBD | 5 years | |
| Surgical recurrent rate in Crohn's disease |
Not provided
Inclusion Criteria:
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adeline GERMAIN, MD, PhD | Contact | +33383153120 | a.germain@chru-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Adeline GERMAIN, MD, PhD | CHRU Nancy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Nancy | Recruiting | Vandœuvre-lès-Nancy | 54510 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| 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 |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |