PRognOstiC valuE of rEd Density in Ulcerative Colitis

NCT04408703 | Completed DMC

• 1 other identifier: s63012
• Study Type: observational
• Target: 243
• Locations: 1 country
• Sites: 2

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.

Conditions

Ulcerative Colitis

Keywords

Endoscopy; Artificial intelligence; Image analysis; Precision medicine; Inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• endoscopic remission Mayo

  week 52

• endoscopic remission UCEIS

  week 52

Other Outcomes (3)

• correlation biomarker

  week 52

• correlation histological score

  week 52

• correlation endoscopic score

  week 52

Study Arms (1)

Ulcerative colitis in clinical remission

Clinical remission with SCCAI \<3 at baseline and stable remission for the last 3 months

Diagnostic Test: Red Density

Interventions

Red Density DIAGNOSTIC_TEST

Image analysis of endoscopic images in patients with ulcerative colitis

Ulcerative colitis in clinical remission

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with ulcerative colitis in clinical remission

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Sapporo Medical University: collaborator
• Imelda GI Clinical Research Center: collaborator

Study Sites (2)

Imelda GI clinical research center

Bonheiden, 2820, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 31915237 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum albumin, faecal calprotectin, C-reactive protein, thrombocytosis and haemoglobin

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Raf Bisschops, MD PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

• Peter Bossuyt, MD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: May 29, 2020
• Study Start: August 3, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: June 27, 2024

Record last verified: 2020-05

Locations

BE (2)