MedTrace Logo

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 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-08-18

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

UCRI

Biomarker panel and algorithm

Sponsors & Collaborators

  • University of California, Davis

    collaborator OTHER

  • University of California, Irvine

    collaborator OTHER

  • University of Chicago

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Crohn's and Colitis Foundation

    collaborator OTHER

  • Glycominds, LLC

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-24
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04897282 on ClinicalTrials.gov