PRognOstiC valuE of rEd Density in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— PROCEED-UC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04408703
• Other study ID #: s63012
• Status: Not yet recruiting
• Start date: June 2020
• Est. completion date: June 2022

Study information

• Verified date: May 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Peter Bossuyt, MD
• Phone: +3215505165
• Email: peter.bossuyt[@]imelda.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 243
• Est. completion date: June 2022
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Diagnostic Test:
• Red Density
Image analysis of endoscopic images in patients with ulcerative colitis

Locations

Country	Name	City	State
Belgium	Imelda GI clinical research center	Bonheiden
Belgium	UZ Leuven	Leuven

Sponsors (3)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Imelda GI Clinical Research Center, Sapporo Medical University

Country where clinical trial is conducted

Belgium, 

References & 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 Jan 8. pii: gutjnl-2019-320056. doi: 10.1136/gutjnl-2019-320056. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	correlation endoscopic score	Correlation between RD scores and Mayo endoscopic subscore and UCEIS at any point in the study.	week 52
Primary	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	endoscopic remission Mayo	Number of patients with Mayo endoscopic subscore of 0 after 52 weeks correlated to the RD score at baseline.	week 52
Secondary	endoscopic remission UCEIS	Number of patients with UCEIS of 0 after 52 weeks correlated to the RD score at baseline.	week 52