Prospective Multicenter Trial to Determine the Efficacy and Outcome of the UCRI Biomarker Panel and Algorithm to Detect Mucosal Healing in Moderate to Severe Ulcerative Colitis Patients.

NCT04897282 | Unknown

• 1 other identifier: UCRI-1020
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine the efficacy and outcome of the UCRI (an in-vitro diagnostics device in the form of a blood test and an algorithm) as a tool to detect mucosal healing (level of inflammation in the colon) in people with moderate-to-severe ulcerative colitis treated with anti-TNFα. Another reason is to explore additional biomarkers in blood, stool or voice to detect disease activity and/or mucosal healing. A tool to detect the level of inflammation in the colon based on blood, stool or voice biomarkers may reduce the need or the number of invasive endoscopic procedures. This is an observational study and no treatment decision nor clinical intervention will be done based on results during this study and all collected data will be used only for the goal of the study and for obtaining FDA IDE for a follow-up study.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (3)

• UCRI panel validation

  Accuracy as measured by ROC curve (receiver operating characteristic curve)

  24 weeks

• UCRI panel validation

  PPV - Positive Predicative Value: proportions of positive tests that are true positive.

  24 weeks

• UCRI panel validation

  NPV - Negative Predicative Value: proportions of negative tests that are true negative.

  24 weeks

Secondary Outcomes (1)

• fCal comparison analysis

  24 weeks

Other Outcomes (1)

• UCRI prediction value

  0-14 weeks

Interventions

UCRI DIAGNOSTIC_TEST

Biomarker panel and algorithm

Eligibility Criteria

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

Study Population

Subjects will be between the ages of 18 and 65 with a diagnosis of UC and MES = 2 or 3. and intend to start or switch anti-TNFa treatment. Women who are pregnant will also be excluded. Patients who are unable to undergo endoscopic evaluations due to proctitis will also be excluded, as well as patients who have a demonstrated history of steroid refraction. To avoid the 2nd endoscopic assessment time fluctuations patients under anti-TNFa dose escalation or dose adjustment regimen will be excluded.

You may qualify if:

• Ulcerative colitis patients with Mayo Endoscopic Subscore of 2-3
• Start/switch anti -TNFa treatment
• Capable of at-home fCal testing

You may not qualify if:

• Pregnant women
• anti -TNFa dose escalation/adjustment
• Inability to undergo endoscopic assessments due to Proctitis
• Diagnosed with infectious diseases
• Steroid refractory

Sponsors & Collaborators

• Glycominds, LLC: lead
• University of California, Davis: collaborator
• University of California, Irvine: collaborator
• University of Chicago: collaborator
• Weill Medical College of Cornell University: collaborator
• Crohn's and Colitis Foundation: collaborator

Study Sites (1)

UC Davis Inflammatory Bowel Disease Center

Sacramento, California, 95816, United States

RECRUITING

Related Publications (2)

• de Bruyn M, Ringold R, Martens E, Ferrante M, Van Assche G, Opdenakker G, Dukler A, Vermeire S. The Ulcerative Colitis Response Index for Detection of Mucosal Healing in Patients Treated With Anti-tumour Necrosis Factor. J Crohns Colitis. 2020 Feb 10;14(2):176-184. doi: 10.1093/ecco-jcc/jjz125.

  PMID: 31628842 BACKGROUND

• Koon HW, Shih DQ, Chen J, Bakirtzi K, Hing TC, Law I, Ho S, Ichikawa R, Zhao D, Xu H, Gallo R, Dempsey P, Cheng G, Targan SR, Pothoulakis C. Cathelicidin signaling via the Toll-like receptor protects against colitis in mice. Gastroenterology. 2011 Nov;141(5):1852-63.e1-3. doi: 10.1053/j.gastro.2011.06.079. Epub 2011 Jul 14.

  PMID: 21762664 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, Serum, Stool

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Avinoam A Dukler, PhD

CONTACT

8057912094; ucri@glycominds.com

Study Design

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

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 21, 2021
• Study Start: August 24, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)