An observational study in Ulcerative Colitis Flare, sponsored by Radboud University Medical Center. Status unknown at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-11.
Sponsored by Radboud University Medical Center · Observational
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.
1,074 studies on the registry are indexed under Colitis; 133 are open to participants now.
This study's planned enrollment of 40 is below the median of 105 across 248 observational studies indexed under Colitis.
Browse Colitis studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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40 adult participants diagnosed with Ulcerative colitis and treated at the department of gasteroenterology of the Radboudumc.
Exclusion Criteria:
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 1.5 years
For 40 patients: height
Height in centimeter, combined with weight to get to BMI (kg/m\^2)
Time frame: Through study completion, an average of 1.5 years
For 40 patients: weight
Weight in kilograms, combined with height to get to BMI (kg/m\^2)
Time frame: Through study completion, an average of 1.5 years
For 40 patients: smoking status
1. Current/active smoker 2. Previous smoker 3. Never smoked 4. Not described
Time frame: Through study completion, an average of 1.5 years
For 40 patients: montreal classification
1. E1: ulcerative proctitis 2. E2: left-sided UC (distal to splenic flexure) 3. E3: Entensive UC (pancolitis)
Time frame: Through study completion, an average of 1.5 years
For 40 patients: SCCAI-score
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
Time frame: Through study completion, an average of 1.5 years
For 40 patients: Mayo score (based on physician rating of endoscopic disease activity)
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)
Time frame: Through study completion, an average of 1.5 years
For 40 patients: Medication history and current medication
anti-TNF, Vedolizumab, Janus kinase inhibitors, thiopurine, methotrexate, aminosalicylates, corticosteroids (grams of medication/day)
Time frame: Through study completion, an average of 1.5 years
For 40 patients: Feacel calprotectin
mg/kg feces
Time frame: Through study completion, an average of 1.5 years
For 40 patients: Albumin
g/L
Time frame: Through study completion, an average of 1.5 years
For 40 patients: infections in stool
yes/no
Time frame: Through study completion, an average of 1.5 years
Blood parameters
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)
Time frame: Through study completion, an average of 1.5 years
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center