Ulcerative Colitis
Conditions
Keywords
Endoscopy, Artificial intelligence, Image analysis, Precision medicine, Inflammatory bowel disease
Brief summary
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.
Interventions
DIAGNOSTIC_TESTRed Density
Image analysis of endoscopic images in patients with ulcerative colitis
Sponsors
Sapporo Medical University
Imelda GI Clinical Research Center
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of UC for at least 3 months * Clinical remission with SCCAI \<3 at baseline and stable remission for the last 3 months * Ability to give informed consent by the patient or legal representative in case of minority.
Exclusion criteria
* Any contraindication for sigmoidoscopy or undergoing biopsies of the rectosigmoid. * Uncontrolled coagulopathy. * Any planned change in UC related treatment (both escalation and de-escalation) after the baseline endoscopy * Planned UC related surgery * Previous subtotal or total colectomy * Short bowel, ileostomy or colostomy * Pregnancy at baseline * Age younger than 16 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sustained clinical remission | week 52 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| endoscopic remission UCEIS | week 52 | Number of patients with UCEIS of 0 after 52 weeks correlated to the RD score at baseline. |
| endoscopic remission Mayo | week 52 | Number of patients with Mayo endoscopic subscore of 0 after 52 weeks correlated to the RD score at baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| correlation biomarker | week 52 | Correlation between RD scores and fecal calprotectin, C-reactive protein (CRP), platelet count and haemoglobin at any point in the study. |
| correlation histological score | week 52 | Correlation between RD scores and Geboes histological score, the Nancy and the Robarts histological index at any point in the study. |
| correlation endoscopic score | week 52 | Correlation between RD scores and Mayo endoscopic subscore and UCEIS at any point in the study. |
Countries
Belgium
Outcome results
None listed