PRognOstiC valuE of rEd Density in Ulcerative Colitis (PROCEED-UC)

PRognOstiC valuE of rEd Density in Ulcerative Colitis: PROCEED-UC STUDY

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Diagnostic test: Red Density

• Study Type: Observational
• Enrollment (Actual): 243

Contacts and Locations

Study Locations

• Belgium
  • Bonheiden, Belgium, 2820
    • Imelda GI Clinical Research Center
  • Leuven, Belgium, 3000
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with ulcerative colitis in clinical remission

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ulcerative colitis in clinical remission; Clinical remission with SCCAI <3 at baseline and stable remission for the last 3 months	Diagnostic test: Red Density; Image analysis of endoscopic images in patients with ulcerative colitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	week 52

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Imelda GI Clinical Research Center; Sapporo Medical University
• Investigators: Principal Investigator: Peter Bossuyt, MD, UZ Leuven; Principal Investigator: Raf Bisschops, MD PhD, UZ Leuven

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: May 25, 2020
• First Submitted That Met QC Criteria: May 25, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Endoscopy; Precision medicine; Artificial intelligence; Inflammatory bowel disease; Image analysis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: s63012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No