Basal Instincts: Towards Better Understanding of Basal Cell Function in Chronic Rhinosinusitis With Nasal Polyps

NCT ID: NCT06129552

Last Updated: 2024-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-19

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Rhinosinusitis With Nasal Polyps Allergic Rhinitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy controls

Conchotomy, aesthetic nose surgery or functional endoscopic sinus operation

Intervention Type PROCEDURE

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.

CRSwNP patients

Conchotomy, aesthetic nose surgery or functional endoscopic sinus operation

Intervention Type PROCEDURE

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.

AR patients

Conchotomy, aesthetic nose surgery or functional endoscopic sinus operation

Intervention Type PROCEDURE

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.

Interventions

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Conchotomy, aesthetic nose surgery or functional endoscopic sinus operation

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peter Hellings

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Peter Hellings, MD, PhD

Role: CONTACT

+32 16 33 23 42

Dominique Bullens, MD, PhD

Role: CONTACT

+32 16 34 13 38

Facility Contacts

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dominique bullens, MD PhD

Role: primary

+3216341338

Daan Rodiers, MsC

Role: backup

+3216346165

Other Identifiers

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S67788

Identifier Type: -

Identifier Source: org_study_id

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