Clinical trial NCT06129552: Basal Instincts: Towards Better Understanding of Basal Cell Function in Chronic Rhinosinusitis With Nasal Polyps
Official title: Basal Instincts: Towards Better Understanding of Basal Cell Function in Chronic Rhinosinusitis With Nasal Polyps
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Allergic Rhinitis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2023-11-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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)

Brief 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.

Detailed description: The investigators want to use patient and healthy control samples to study/compare the following aspects in vitro:

1. Investigate differences in epithelial and basal cell functions and differentiation characteristics.
2. 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.
3. Investigate basal cell activation via different environmental triggers through TLR stimulation.
4. Look at the genetic imprinting of basal cells before and after being exposed to specific triggers.
5. Investigate whether the secreted proteins from basal cells are chemotactic for other cell populations.
6. Investigate the interaction between basal and regulatory T cells.

Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18
* Males and females

Exclusion Criteria:

* CRSwNP
* AR
* Smoker, or \< 1-year ex-smoker
* Underlying systematic pathology (Morbus Wegener or Churg Strauss Syndrome for example)

Primary outcomes:
measure: Functional differences between epithelial/basal cells from CRSwNP samples in comparison to healthy controls assessed with functional assays.
timeFrame: 12-24 months
measure: Characterization of differences in gene expression profiles and epithelial populations in/between CRSwNP and healthy controls assessed with different sequencing techniques.
timeFrame: 9-18 months
measure: Changes and interactions in the basal and regulatory T-cell axis between healthy and CRSwNP-isolated cells will be studied through co-culture experiments.
timeFrame: 9-18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Peter Hellings
Study officials:
References: