Crohn DiseaseNCT06485193
The Innate Immune Response and Enteric Nervous System in Crohn's Disease.
An observational study of Crohn Disease, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
The study aims to explore the relationships between inflammation, nerve changes, and the expression of interferon-stimulated proteins in inflamed and non-inflamed bowel areas from patients with Crohn's disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Immunohistochemistry
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Sep 2023to 1 Jun 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Crohn's disease
Who may be able to join
- Histological preparations (tissue samples) from patients with Crohn's disease who have undergone bowel resection at Aalborg University Hospital in the period from 2012 to 2023.
Who cannot join
- If the tissue material does not include the ileocecal region.
- If the pathology report does not indicate that there is tissue material from both inflamed and non-inflamed areas.
- If the patient has registered a prohibition against research in the Tissue Utilization Registry.
- The selection of cases starts with the most recent (by date) and stops when 25 suitable cases are found.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Det medfødte Immunforsvar og Det Enteriske Nervesystem Ved Crohns Sygdom
The study aims to explore the relationships between inflammation, nerve changes, and the expression of interferon-stimulated proteins in inflamed and non-inflamed bowel areas from patients with Crohn's disease. Crohn's disease is a chronic inflammatory condition with complex causes and mechanisms that remain uncertain despite extensive research.
Methods and Procedures This exploratory study utilizes tissue samples from a clinical biobank at Aalborg University Hospital. The samples are paraffin-embedded blocks from which tissue sections are prepared for immunohistochemical and histological staining. The study focuses on assessing the expression of interferon-stimulated proteins through optimized immunohistochemical staining methods, ensuring reproducibility via automated machines. The protein expressions are then analyzed qualitatively and semi-quantitatively and compared with structural changes in the bowel tissues.
- Conditions
- Crohn Disease
- Being tested
- Immunohistochemistry
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunohistochemistryDiagnostic test
Immunohistochemical analysis of archived diagnostic tissue samples.
What is being measured
The primary outcome is the main question the study is designed to answer.
MxA expression
Immunohistochemical Mxa expression
Measured: June 1 2024
Secondary outcomes (1)
Enterovirus positivity
pan-enterovirus immunohistochemistry
Measured: June 1 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start4 Sep 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Why it stopped: Preliminary results showed no signs of associations in the data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Thomsen, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485193
- Sponsor's protocol ID
- N-20230024
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Det medfødte Immunforsvar og Det Enteriske Nervesystem Ved Crohns Sygdom
- ClinicalTrials.gov ID
- NCT06485193
- Acronym / sponsor ID
- N-20230024
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Preliminary results showed no signs of associations in the data.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to explore the relationships between inflammation, nerve changes, and the expression of interferon-stimulated proteins in inflamed and non-inflamed bowel areas from patients with Crohn's disease. Crohn's disease is a chronic inflammatory condition with complex causes and mechanisms that remain uncertain despite extensive research.
Methods and Procedures This exploratory study utilizes tissue samples from a clinical biobank at Aalborg University Hospital. The samples are paraffin-embedded blocks from which tissue sections are prepared for immunohistochemical and histological staining. The study focuses on assessing the expression of interferon-stimulated proteins through optimized immunohistochemical staining methods, ensuring reproducibility via automated machines. The protein expressions are then analyzed qualitatively and semi-quantitatively and compared with structural changes in the bowel tissues.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Crohn's disease
Key inclusion criteria (1 listed)
- Histological preparations (tissue samples) from patients with Crohn's disease who have undergone bowel resection at Aalborg University Hospital in the period from 2012 to 2023.
Key exclusion criteria (4 listed)
- If the tissue material does not include the ileocecal region.
- If the pathology report does not indicate that there is tissue material from both inflamed and non-inflamed areas.
- If the patient has registered a prohibition against research in the Tissue Utilization Registry.
- The selection of cases starts with the most recent (by date) and stops when 25 suitable cases are found.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunohistochemistryImmunohistochemical analysis of archived diagnostic tissue samples. | Diagnostic test | – |
Primary outcome
MxA expression
Time frame: June 1 2024
Immunohistochemical Mxa expression
1 secondary outcome
Enterovirus positivity
Time frame: June 1 2024
Results and safety
The study was stopped early (reason given: Preliminary results showed no signs of associations in the data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Aalborg University Hospital at 1 site in Denmark.
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 1 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: stopped early, as of the sponsor's last update on 3 Jul 2024. 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 Denmark. 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?
The study was stopped early (reason given: Preliminary results showed no signs of associations in the data.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MxA expression (time frame: June 1 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2024.