Chronic Rhinosinusitis With Nasal PolypsNCT06129552
Basal Instincts: Towards Better Understanding of Basal Cell Function in Chronic Rhinosinusitis With Nasal Polyps
An observational study of Chronic Rhinosinusitis With Nasal Polyps and Allergic Rhinitis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
During this project, the investigators want to explore in vitro changes in basal cells and the crosstalk with residing immune cells as potential pathogenic mechanisms in CRSwNP vs healthy controls by using surgically resected patient samples. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps, Allergic Rhinitis
- What is being tested?
- Conchotomy, aesthetic nose surgery or functional endoscopic sinus operation
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Dec 2023to Dec 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CRSwNP patients: Inclusion Criteria: * Patients over the age of 18 * Males and females * Patient with symptoms of chronic rhinosinusitis * Presence of nasal polyps Exclusion Criteria: * AR * Smoker, or < 1-year ex-smoker * Patient with cystic fibrosis * Only the presence of an antrochoanal polyp * Underlying systematic pathology (Morbus Wegener or Churg Strauss Syndrome for example) AR patients: Inclusion criteria: * Patients over the age of 18 * Males and females * Patients with AR symptoms Exclusion criteria: * CRSwNP * Smoker, or < 1-year ex-smoker * Underlying systematic pathology (Morbus Wegener or Churg Strauss Syndrome for example)
Who may be able to join
- Patients over the age of 18
- Males and females
Who cannot join
- CRSwNP
- AR
- Smoker, or < 1-year ex-smoker
- Underlying systematic pathology (Morbus Wegener or Churg Strauss Syndrome for example)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Peter Hellings
Leuven, 3000
dominique bullens, MD PhD, +3216341338, dominique.bullens@kuleuven.be
Daan Rodiers, MsC, +3216346165, daan.rodiers@kuleuven.be
About this study
During this project, the investigators want to explore in vitro changes in basal cells and the crosstalk with residing immune cells as potential pathogenic mechanisms in CRSwNP vs healthy controls by using surgically resected patient samples.
Read the detailed description
The investigators want to use patient and healthy control samples to study/compare the following aspects in vitro:
- Investigate differences in epithelial and basal cell functions and differentiation characteristics.
- Characterize the differences in epithelial cell populations and gene expression patterns. Also include an AR subset, to see if changes are specific for CRSwNP or more general for type 2 inflammatory disease of the upper airways.
- Investigate basal cell activation via different environmental triggers through TLR stimulation.
- Look at the genetic imprinting of basal cells before and after being exposed to specific triggers.
- Investigate whether the secreted proteins from basal cells are chemotactic for other cell populations.
- Investigate the interaction between basal and regulatory T cells.
- Being tested
- Conchotomy, aesthetic nose surgery or functional endoscopic sinus operation
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conchotomy, aesthetic nose surgery or functional endoscopic sinus operationProcedure or surgery
Conchotomy involves the reduction or removal of hypertrophic nasal turbinates, aesthetic nose surgery is a surgical procedure that aims to enhance the appearance of the nose, while functional endoscopic sinus surgery is a minimally invasive procedure focused on treating sinus conditions by removing obstructions and improving sinus drainage.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Not described Receives: Procedure: Conchotomy, aesthetic nose surgery or functional endoscopic sinus operation | |
| CRSwNP patients | Not described Receives: Procedure: Conchotomy, aesthetic nose surgery or functional endoscopic sinus operation | |
| AR patients | Not described Receives: Procedure: Conchotomy, aesthetic nose surgery or functional endoscopic sinus operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional differences between epithelial/basal cells from CRSwNP samples in comparison to healthy controls assessed with functional assays.
Multiple techniques and functional assays will be used to fully investigate the functional differences between epithelial/basal cells isolated from healthy and CRSwNP samples. The differences in barrier composition will be assessed through TEER measurements (Ω × cm2) and FD4 permeability assays (ng/ml). Moreover, barrier composition is investigated by examining differences in membrane markers and junction expression through immunofluorescence and RT-qPCR. Finally, primary isolated cells will be used to assess protein levels through immunostainings, flow cytometry, and Western blots.
Measured: 12-24 months
Characterization of differences in gene expression profiles and epithelial populations in/between CRSwNP and healthy controls assessed with different sequencing techniques.
To characterize differences in gene expression, or identify specific genes/cell populations that can contribute to CRSwNP, scRNA-sequencing will be performed, as well as bulk RNA sequencing. Depending on these results, specific triggers or receptors that can contribute to CRSwNP will be investigated by stimulation experiments. Besides, the effect on epigenetic imprinting before and after stimulation by performing ATAC-sequencing or DNA methylation profiling will be studied as well.
Measured: 9-18 months
Changes and interactions in the basal and regulatory T-cell axis between healthy and CRSwNP-isolated cells will be studied through co-culture experiments.
The interaction between basal and regulatory T cells in relation to homeostasis and regeneration, and how this might change or contribute in/to CRSwNP will be investigated by co-culturing these cells. This will be assessed through the analysis of the supernatants using the Olink platform to investigate cytokines etc. Besides, there will be bulk RNA sequencing to look at changes in gene expression, as well as proliferation and growth assays to see the effect of T cells on basal cells and vice versa. To look at functional changes we can asses different functional assays and techniques (see outcome 1).
Measured: 9-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start19 Dec 2023
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129552
- Sponsor's protocol ID
- S67788
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2023
- Last updated
- 22 Mar 2024
- Results posted
- 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 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basal Instincts: Towards Better Understanding of Basal Cell Function in Chronic Rhinosinusitis With Nasal Polyps
- ClinicalTrials.gov ID
- NCT06129552
- Acronym / sponsor ID
- S67788
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Nov 2023 (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.
During this project, the investigators want to explore in vitro changes in basal cells and the crosstalk with residing immune cells as potential pathogenic mechanisms in CRSwNP vs healthy controls by using surgically resected patient samples.
Detailed description
The investigators want to use patient and healthy control samples to study/compare the following aspects in vitro:
- Investigate differences in epithelial and basal cell functions and differentiation characteristics.
- Characterize the differences in epithelial cell populations and gene expression patterns. Also include an AR subset, to see if changes are specific for CRSwNP or more general for type 2 inflammatory disease of the upper airways.
- Investigate basal cell activation via different environmental triggers through TLR stimulation.
- Look at the genetic imprinting of basal cells before and after being exposed to specific triggers.
- Investigate whether the secreted proteins from basal cells are chemotactic for other cell populations.
- Investigate the interaction between basal and regulatory T cells.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Procedure: Conchotomy, aesthetic nose surgery or functional endoscopic sinus operation |
| CRSwNP patients | – | Procedure: Conchotomy, aesthetic nose surgery or functional endoscopic sinus operation |
| AR patients | – | Procedure: Conchotomy, aesthetic nose surgery or functional endoscopic sinus operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CRSwNP patients: Inclusion Criteria: * Patients over the age of 18 * Males and females * Patient with symptoms of chronic rhinosinusitis * Presence of nasal polyps Exclusion Criteria: * AR * Smoker, or < 1-year ex-smoker * Patient with cystic fibrosis * Only the presence of an antrochoanal polyp * Underlying systematic pathology (Morbus Wegener or Churg Strauss Syndrome for example) AR patients: Inclusion criteria: * Patients over the age of 18 * Males and females * Patients with AR symptoms Exclusion criteria: * CRSwNP * Smoker, or < 1-year ex-smoker * Underlying systematic pathology (Morbus Wegener or Churg Strauss Syndrome for example)
Key inclusion criteria (2 listed)
- Patients over the age of 18
- Males and females
Key exclusion criteria (4 listed)
- CRSwNP
- AR
- Smoker, or < 1-year ex-smoker
- Underlying systematic pathology (Morbus Wegener or Churg Strauss Syndrome for example)
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 |
|---|---|---|
| Conchotomy, aesthetic nose surgery or functional endoscopic sinus operationConchotomy involves the reduction or removal of hypertrophic nasal turbinates, aesthetic nose surgery is a surgical procedure that aims to enhance the appearance of the nose, while functional endoscopic sinus surgery is a minimally invasive procedure focused on treating sinus conditions by removing obstructions and improving sinus drainage. | Procedure or surgery | AR patients, CRSwNP patients, Healthy controls |
Primary outcome
Functional differences between epithelial/basal cells from CRSwNP samples in comparison to healthy controls assessed with functional assays.
Time frame: 12-24 months
Multiple techniques and functional assays will be used to fully investigate the functional differences between epithelial/basal cells isolated from healthy and CRSwNP samples. The differences in barrier composition will be assessed through TEER measurements (Ω × cm2) and FD4 permeability assays (ng/ml). Moreover, barrier composition is investigated by examining differences in membrane markers and junction expression through immunofluorescence and RT-qPCR. Finally, primary isolated cells will be used to assess protein levels through immunostainings, flow cytometry, and Western blots.
Characterization of differences in gene expression profiles and epithelial populations in/between CRSwNP and healthy controls assessed with different sequencing techniques.
Time frame: 9-18 months
To characterize differences in gene expression, or identify specific genes/cell populations that can contribute to CRSwNP, scRNA-sequencing will be performed, as well as bulk RNA sequencing. Depending on these results, specific triggers or receptors that can contribute to CRSwNP will be investigated by stimulation experiments. Besides, the effect on epigenetic imprinting before and after stimulation by performing ATAC-sequencing or DNA methylation profiling will be studied as well.
Changes and interactions in the basal and regulatory T-cell axis between healthy and CRSwNP-isolated cells will be studied through co-culture experiments.
Time frame: 9-18 months
The interaction between basal and regulatory T cells in relation to homeostasis and regeneration, and how this might change or contribute in/to CRSwNP will be investigated by co-culturing these cells. This will be assessed through the analysis of the supernatants using the Olink platform to investigate cytokines etc. Besides, there will be bulk RNA sequencing to look at changes in gene expression, as well as proliferation and growth assays to see the effect of T cells on basal cells and vice versa. To look at functional changes we can asses different functional assays and techniques (see outcome 1).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 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.
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 Chronic Rhinosinusitis With Nasal Polyps and Allergic Rhinitis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 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: looking for participants now, as of the sponsor's last update on 22 Mar 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Hellings, MD, PhD (+32 16 33 23 42, peter.hellings@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional differences between epithelial/basal cells from CRSwNP samples in comparison to healthy controls assessed with functional assays. (time frame: 12-24 months). The study lists 3 primary outcomes in all. 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 22 Mar 2024.