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Ulcerative Colitis FlareImmUniverseNCT05680883

Local and Systemic Immunoprofiling of Patients Diagnosed With Ulcerative Colitis

An observational study of Ulcerative Colitis Flare, run by Radboud University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ulcerative Colitis Flare
How many people
40 participants
Where
1 siteNetherlands
Study dates
5 May 2022to 5 Nov 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hans Koenen contact

+31 243693478

Hans.Koenen@radboudumc.nl

Laurien Waaijer contact

+31629290219

Laurien.Waaijer@radboudumc.nl

Netherlands1 site, 1 recruiting

  • RadboudUMC

    Nijmegen, Gelderland, 6525EX

    Hans Koenen, Hans.Koenen@radboudumc.nl

    Laurien Waaijer, +31629290219, Laurien.Waaijer@radboudumc.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: 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.

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Through study completion, an average of 1.5 years

  2. 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

    Measured: Through study completion, an average of 1.5 years

  3. 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

    Measured: Through study completion, an average of 1.5 years

  4. Localizing immune cells of interest of inflamed and uninflamed biopsies

    By using immunohistochemistry: quantified by cells per field

    Measured: Through study completion, an average of 1.5 years

Secondary outcomes (11)

  1. For 40 patients: height

    Height in centimeter, combined with weight to get to BMI (kg/m^2)

    Measured: Through study completion, an average of 1.5 years

  2. For 40 patients: weight

    Weight in kilograms, combined with height to get to BMI (kg/m^2)

    Measured: Through study completion, an average of 1.5 years

  3. For 40 patients: smoking status

    1. Current/active smoker
    2. Previous smoker
    3. Never smoked
    4. Not described

    Measured: Through study completion, an average of 1.5 years

  4. For 40 patients: montreal classification

    1. E1: ulcerative proctitis
    2. E2: left-sided UC (distal to splenic flexure)
    3. E3: Entensive UC (pancolitis)

    Measured: Through study completion, an average of 1.5 years

  5. 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

    Measured: Through study completion, an average of 1.5 years

  6. 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)

    Measured: Through study completion, an average of 1.5 years

  7. For 40 patients: Medication history and current medication

    anti-TNF, Vedolizumab, Janus kinase inhibitors, thiopurine, methotrexate, aminosalicylates, corticosteroids (grams of medication/day)

    Measured: Through study completion, an average of 1.5 years

  8. For 40 patients: Feacel calprotectin

    mg/kg feces

    Measured: Through study completion, an average of 1.5 years

  9. For 40 patients: Albumin

    g/L

    Measured: Through study completion, an average of 1.5 years

  10. For 40 patients: infections in stool

    yes/no

    Measured: Through study completion, an average of 1.5 years

  11. 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)

    Measured: Through study completion, an average of 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2023
  2. Study start5 May 2022
  3. Primary completion5 Nov 2023 (estimated)
  4. Study completion5 Nov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05680883
Sponsor's protocol ID
NL78552.091.21
Acronym
ImmUniverse
Status last verified
Nov 2022
First submitted
17 Nov 2022
Last updated
11 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis Flare, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hans Koenen (+31 243693478, Hans.Koenen@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05680883.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.

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