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| Name | Class |
|---|---|
| Sapporo Medical University | OTHER |
| Imelda GI Clinical Research Center | OTHER |
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Observational prospective multicenter study: baseline assessement of the disease activity by an automated endoscopic tool and follow up of 52 weeks to evaluate sustained clinical remission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulcerative colitis in clinical remission | Clinical remission with SCCAI <3 at baseline and stable remission for the last 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red Density | Diagnostic Test | Image analysis of endoscopic images in patients with ulcerative colitis |
|
| Measure | Description | Time Frame |
|---|---|---|
| sustained clinical remission | Number of patients with sustained clinical remission at week 52, defined as simple clinical colitis activity index (SCCAI) <3 AND no need for initiation of new treatment, escalation of therapy, UC related hospitalization or colectomy correlated to the RD score at baseline. | week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| endoscopic remission Mayo | Number of patients with Mayo endoscopic subscore of 0 after 52 weeks correlated to the RD score at baseline. | week 52 |
| endoscopic remission UCEIS | Number of patients with UCEIS of 0 after 52 weeks correlated to the RD score at baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| correlation biomarker | Correlation between RD scores and fecal calprotectin, C-reactive protein (CRP), platelet count and haemoglobin at any point in the study. | week 52 |
| correlation histological score |
Inclusion Criteria:
Exclusion Criteria:
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Patients with ulcerative colitis in clinical remission
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| Name | Affiliation | Role |
|---|---|---|
| Raf Bisschops, MD PhD | UZ Leuven | Principal Investigator |
| Peter Bossuyt, MD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imelda GI clinical research center | Bonheiden | 2820 | Belgium | |||
| UZ Leuven |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31915237 | Background | Bossuyt P, Nakase H, Vermeire S, de Hertogh G, Eelbode T, Ferrante M, Hasegawa T, Willekens H, Ikemoto Y, Makino T, Bisschops R. Automatic, computer-aided determination of endoscopic and histological inflammation in patients with mild to moderate ulcerative colitis based on red density. Gut. 2020 Oct;69(10):1778-1786. doi: 10.1136/gutjnl-2019-320056. Epub 2020 Jan 8. |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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serum albumin, faecal calprotectin, C-reactive protein, thrombocytosis and haemoglobin
| week 52 |
Correlation between RD scores and Geboes histological score, the Nancy and the Robarts histological index at any point in the study.
| week 52 |
| correlation endoscopic score | Correlation between RD scores and Mayo endoscopic subscore and UCEIS at any point in the study. | week 52 |
| Leuven |
| 3000 |
| Belgium |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |