Phenotyping of Type 2 Inflammation Profile by Rheology of Nasal Secretions and Tissue Quantification of Eosinophilic Polymorphonuclear Cells in the Middle Turbinate

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity Hospital, Montpellier

About this trial

This monocentric, interventional study (category RIPH2) aims to characterize the rheological properties of sinonasal secretions in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). The primary objective is to determine differences in mucus viscosity between CRSwNP patients and a control group. By establishing a correlation between local rheology and systemic Type 2 inflammation biomarkers, the study seeks to develop a non-invasive, rapid "point-of-care" tool to refine patient phenotyping and improve the personalization of biological treatments.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient requiring sinonasal surgery

Nasal congestion

Rhinorrhea (anterior/posterior)

Or a Facial pain/pressure

Disqualifiers

Inability to provide a sinonasal secretion sample by blowing

Conditions causing secondary nasal polyposis (e.g., cystic fibrosis, ciliary dyskinesia, immune disorders, allergic fungal sinusitis)

Illiteracy

Lack of consent

Trial design

Design model

Single group

Treatments tested in this trial

  • Sinonasal sample collection and inflammatory assessment

    Procedure/Surgery

    Collection of sinonasal secretions by blowing onto an aluminum plate Collection of blood sample: 7 ml for serum isolation to create a serum bank Biopsy of the middle turbinate head: under nasal endoscopy, a millimetric tissue sample will be taken from the middle turbinate mucosa using biopsy forceps

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Characterize and compare patients with and without CRSwNPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Comparison of viscosity of sinonasal secretions

Measuring mucus viscosity (G", in Pa) with the Rheomuco device. Comparison of viscosity between CRSwNP (Chronic Rhinosinusitis with Nasal Polyposispatients) patients and a control group of patients without CRSwNP

Time frame
Day 1

Secondary outcomes

1

Comparison of elasticity (G' [Pa]) of sinonasal secretions

Measuring mucus elasticity (G, in Pa) with the Rheomuco device. Comparison of viscosity between CRSwNP and a control group of patients without CRSwNP

Time frame
Day 1
2

Comparison of critical stress of sinonasal secretions

Measuring mucus critical stress (SigmaC) with the Rheomuco device. Comparison of viscosity between CRSwNP patients and a control group of patients without CRSwNP

Time frame
Day 1
3

Comparison of tissue eosinophilia

Quantification of the number of eosinophils per mm3 in the middle turbinate tissue via histological analysis (HE staining). Comparison between CRSwNP patients and the control group.

Time frame
Day 1
4

Comparison of circulating eosinophilia

Measurement of blood eosinophil levels (absolute count in cells/mm3 and percentage). Comparison between CRSwNP patients and the control group.

Time frame
Day 1

Other outcomes

Sponsors and contacts

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