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| Name | Class |
|---|---|
| IRCCS San Raffaele | OTHER |
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TIME is an observational study performed on UC and CD patients under endoscopic surveillance for monitoring the clinical activity of their disease.
The main objective of the study is to confirm the therapeutic potential of TREM-1 in inflammatory bowel disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulcerative colitis (UC) | 20 patients with moderate to severe UC under endoscopic surveillance for their disease |
| |
| Crohn's Disease (CD) | 20 patients with moderate to severe CD under endoscopic surveillance for their disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additional biopsies and blood samples | Other | During the endoscopic procedure planned for IBD patients following standard clinical practice, the endoscopist will decide the number and location of additional biopsy samples (up to 8) collected for the study. Participation in this study also requires the removal of three additional blood samples. |
| Measure | Description | Time Frame |
|---|---|---|
| Collection of IBD patient-derived intestinal mucosal explants for testing TREM-1 antagonist | Derivation of RNA and proteins from biopsy specimens upon in vitro exposure to the TREM-1 antagonist | 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of pro-inflammatory cytokines in supernatants of treated explants to evaluate the effect of the TREM-1 antagonist compound | Measurement of pro-inflammatory cytokine concentrations (pg/ml) | 26 months |
| Gene expression in treated explants and other samples to evaluate the effect of the TREM-1 antagonist compound |
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Inclusion Criteria:
Exclusion Criteria:
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The population that will be recruited for this study will be composed of patients with UC or CD under endoscopic surveillance for monitoring the clinical activity of their disease.
The recruited patients will firstly sign the informed consent before undergoing the same day the blood withdrawal and endoscopy according to standard of care practice in the dedicated department, under the direction of the Gastroenterology and Digestive Endoscopy operative unit of the San Raffaele Hospital.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele | Recruiting | Milan | Italy |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
RNAseq analysis |
| 26 months |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |