Local and Systemic Immunoprofiling of Patients Diagnosed With Ulcerative Colitis

NCT05680883 | Unknown DMC

• 1 other identifier: NL78552.091.21
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ulcerative Colitis Flare

Keywords

Immune cells; Inflamed + non-inflamed biopsies + correlated blood samples; Flow cytometry; IHC; Single cell RNA sequencing; Immunoprofiling

Outcome Measures

Primary Outcomes (4)

• Comparing immune cells in blood, inflamed and uninflamed colonic biopsies by means of flow cytometry

  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

  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

  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

  By using immunohistochemistry: quantified by cells per field

  Through study completion, an average of 1.5 years

Secondary Outcomes (11)

• For 40 patients: height

  Through study completion, an average of 1.5 years

• For 40 patients: weight

  Through study completion, an average of 1.5 years

• For 40 patients: smoking status

  Through study completion, an average of 1.5 years

• For 40 patients: montreal classification

  Through study completion, an average of 1.5 years

• For 40 patients: SCCAI-score

  Through study completion, an average of 1.5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

RadboudUMC

Nijmegen, Gelderland, 6525EX, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

EDTA Whole Blood (3x 10mL) and colonic biopsies (4 inflamed and 4 uninflamed)

Central Study Contacts

Hans Koenen

CONTACT

+31 243693478; Hans.Koenen@radboudumc.nl

Laurien Waaijer

CONTACT

+31629290219; Laurien.Waaijer@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: January 11, 2023
• Study Start: May 5, 2022
• Primary Completion: November 5, 2023
• Study Completion: November 5, 2023
• Last Updated: January 11, 2023

Record last verified: 2022-11

Locations

NL (1)