Local and Systemic Immunoprofiling of Patients Diagnosed With Ulcerative Colitis (ImmUniverse)

January 10, 2023 updated by: Radboud University Medical Center

Better Control and Treatment of Ulcerative Colitis by Exploring the Universe of Microenvironment Imposed Tissue Signatures and Their Correlates in Liquid Biopsies

Immune-mediated diseases are extremely diverse - patients with the same diagnosis may see the disease progress in very different ways, and respond differently to treatments. This is because the course of the disease is influenced by multiple factors, including the patient's genes, immune system, environment, and the microbes living in their gut. Furthermore, all of these factors interact with and impact on one another. As a result, it is very hard to predict how the disease will develop in a specific patient, and which treatments will be effective. Hence, mechanistic understanding of this heterogeneity and biomarkers predictive for disease control and therapy response over time are important prerequisites of a future precision medicine in IMIDs. ImmUniverse has been formed as a European transdisciplinary consortium to tackle these unmet needs and to understand the role of the crosstalk between tissue microenvironment and immune cells in disease progression and response to therapy of ulcerative colitis (UC) and atopic dermatitis (AD).

The consortium will combine analysis of tissue-derived signatures with "circulating signatures" detectable in liquid biopsies, employing state-of-the-art profiling technologies to provide new validated diagnostics in IMID that are expected to improve patient management, lead to increased patient well-being and will significantly reduce the socioeconomic burden of these diseases. This study, being Immuniverse work package 5 (WP5), will verify the disease pathway -and mechanism signatures identified in the multi omic discovery WP2 in immune cells in affected tissue and peripheral blood. WP5 aims to further substantiate our understanding of the immune-mediated intestinal disease ulcerative colitis (UC). It will use liquid biopsies (peripheral blood) and affected UC gut inflamed and non-inflamed biopsies to generate transcriptome, proteome, DNA-methylome and miRNA signatures of immune cell subsets and analyse the association between immune cells circulating in peripheral blood and the microenvironment of affected colonic tissue.

Also this WP aims to develop a protocol to analyse and sort living immune cells from cryopreserved tissue. Ultimately, the project's findings should contribute to a better, more precise diagnosis for patients; and better information on how severe the disease is likely to be for each individual patient and how it will progress over time. Finally, the project will make it easier for doctors and patients to monitor how well a treatment is working in the future.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

40 adult participants diagnosed with Ulcerative colitis and treated at the department of gasteroenterology of the Radboudumc.

Description

Inclusion Criteria:

  • Diagnosis of Ulcerative Colitis
  • Age ≥ 18 years
  • Present in the hospital for a regular outpatient visit
  • Willing and able to comply with the study related procedures
  • Provide signed informed consent

Exclusion Criteria:

  • Age ≤ 18 years
  • Unable to give informed consent
  • Unable or unwilling to comply with study-related procedures
  • Crohn's Disease or IBD undiagnosed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing immune cells in blood, inflamed and uninflamed colonic biopsies by means of flow cytometry
Time Frame: Through study completion, an average of 1.5 years
Assessed by differences in Mean Fluorescent Intensity in whole blood sampels vs. inflamed and uninflamed biopsies
Through study completion, an average of 1.5 years
Comparing immune cells in blood, inflamed and uninflamed colonic biopsies by means of flow cytometry
Time Frame: Through study completion, an average of 1.5 years
Assessed by differences in percentages of cell populations in whole blood sampels vs. inflamed and uninflamed biopsies
Through study completion, an average of 1.5 years
Comparing gene expression profiles in blood, inflamed and uninflamed colonic biopsies
Time Frame: Through study completion, an average of 1.5 years
Assessment of mean expression of genes in blood vs. inflamed and uninflamed biopsies by means of single cell RNA sequencing
Through study completion, an average of 1.5 years
Localizing immune cells of interest of inflamed and uninflamed biopsies
Time Frame: Through study completion, an average of 1.5 years
By using immunohistochemistry: quantified by cells per field
Through study completion, an average of 1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
For 40 patients: height
Time Frame: Through study completion, an average of 1.5 years
Height in centimeter, combined with weight to get to BMI (kg/m^2)
Through study completion, an average of 1.5 years
For 40 patients: weight
Time Frame: Through study completion, an average of 1.5 years
Weight in kilograms, combined with height to get to BMI (kg/m^2)
Through study completion, an average of 1.5 years
For 40 patients: smoking status
Time Frame: Through study completion, an average of 1.5 years
  1. Current/active smoker
  2. Previous smoker
  3. Never smoked
  4. Not described
Through study completion, an average of 1.5 years
For 40 patients: montreal classification
Time Frame: Through study completion, an average of 1.5 years
  1. E1: ulcerative proctitis
  2. E2: left-sided UC (distal to splenic flexure)
  3. E3: Entensive UC (pancolitis)
Through study completion, an average of 1.5 years
For 40 patients: SCCAI-score
Time Frame: Through study completion, an average of 1.5 years

Based on 6 variables:

  1. Bowel frequency (day)
  2. Bowel frequency (night)
  3. Urgency of defecation
  4. Blood in stool
  5. General well-being
  6. Extracolonic features
Through study completion, an average of 1.5 years
For 40 patients: Mayo score (based on physician rating of endoscopic disease activity)
Time Frame: Through study completion, an average of 1.5 years

0: normal or inactive disease

1: mild disease (erythema, decreased vascular pattern, mild friability) 2. Moderate disease (marked erythema, absent vascular pattern, friability, erosions) 3. Severe disease (spontaneous bleeding, ulcerations)
Through study completion, an average of 1.5 years
For 40 patients: Medication history and current medication
Time Frame: Through study completion, an average of 1.5 years
anti-TNF, Vedolizumab, Janus kinase inhibitors, thiopurine, methotrexate, aminosalicylates, corticosteroids (grams of medication/day)
Through study completion, an average of 1.5 years
For 40 patients: Feacel calprotectin
Time Frame: Through study completion, an average of 1.5 years
mg/kg feces
Through study completion, an average of 1.5 years
For 40 patients: Albumin
Time Frame: Through study completion, an average of 1.5 years
g/L
Through study completion, an average of 1.5 years
For 40 patients: infections in stool
Time Frame: Through study completion, an average of 1.5 years
yes/no
Through study completion, an average of 1.5 years
Blood parameters
Time Frame: Through study completion, an average of 1.5 years
WBC count (*10^9/L), RBC count (*10^12/L), PLT (*10^9/L), Lymphocytes (*10^9/L), Monocytes (*10^9/L), Neutrophils (*10^9/L), Eosinophils (*10^9/L), Basiphils (*10^9/L)
Through study completion, an average of 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2022

Primary Completion (Anticipated)

November 5, 2023

Study Completion (Anticipated)

November 5, 2023

Study Registration Dates

First Submitted

November 17, 2022

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Estimate)

January 11, 2023

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL78552.091.21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ulcerative Colitis Flare

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe