Clinical trial NCT05680883: Local and Systemic Immunoprofiling of Patients Diagnosed With Ulcerative Colitis
Official title: Better Control and Treatment of Ulcerative Colitis by Exploring the Universe of Microenvironment Imposed Tissue Signatures and Their Correlates in Liquid Biopsies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ulcerative Colitis Flare
Keywords: Immune cells
Inflamed + non-inflamed biopsies + correlated blood samples
Flow cytometry
IHC
Single cell RNA sequencing
Immunoprofiling
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 adult participants diagnosed with Ulcerative colitis and treated at the department of gasteroenterology of the Radboudumc.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparing immune cells in blood, inflamed and uninflamed colonic biopsies by means of flow cytometry
timeFrame: Through study completion, an average of 1.5 years
measure: Comparing immune cells in blood, inflamed and uninflamed colonic biopsies by means of flow cytometry
timeFrame: Through study completion, an average of 1.5 years
measure: Comparing gene expression profiles in blood, inflamed and uninflamed colonic biopsies
timeFrame: Through study completion, an average of 1.5 years
measure: Localizing immune cells of interest of inflamed and uninflamed biopsies
timeFrame: Through study completion, an average of 1.5 years
Secondary outcomes:
measure: For 40 patients: height
timeFrame: Through study completion, an average of 1.5 years
measure: For 40 patients: weight
timeFrame: Through study completion, an average of 1.5 years
measure: For 40 patients: smoking status
timeFrame: Through study completion, an average of 1.5 years
measure: For 40 patients: montreal classification
timeFrame: Through study completion, an average of 1.5 years
measure: For 40 patients: SCCAI-score
timeFrame: Through study completion, an average of 1.5 years
measure: For 40 patients: Mayo score (based on physician rating of endoscopic disease activity)
timeFrame: Through study completion, an average of 1.5 years
measure: For 40 patients: Medication history and current medication
timeFrame: Through study completion, an average of 1.5 years
measure: For 40 patients: Feacel calprotectin
timeFrame: Through study completion, an average of 1.5 years
measure: For 40 patients: Albumin
timeFrame: Through study completion, an average of 1.5 years
measure: For 40 patients: infections in stool
timeFrame: Through study completion, an average of 1.5 years
measure: Blood parameters
timeFrame: Through study completion, an average of 1.5 years
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: RadboudUMC
state: Gelderland
Study officials:
References: