NCT05680883: ImmUniverse

Local and Systemic Immunoprofiling of Patients Diagnosed With Ulcerative Colitis

Status unknown Last updated 11 January 2023

What this trial tests

trial in Ulcerative Colitis Flare in 40 participants. Status unknown.

Timeline

5 May 2022

Primary endpoint
5 November 2023

5 November 2023

Quick facts

Lead sponsor	Radboud University Medical Center
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	40
Start date	5 May 2022
Primary completion	5 November 2023
Estimated completion	5 November 2023
Sites	1 location across Netherlands

Conditions studied

• Ulcerative Colitis Flare — all drugs for Ulcerative Colitis Flare →

Sponsor

Radboud University Medical Center

Who can join

18 and older, female only, with Ulcerative Colitis Flare. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.