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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A01490-49 | Other Identifier | IDRCB |
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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.
The study compares two groups of adult patients undergoing endonasal surgery at Montpellier University Hospital: 30 patients with CRSwNP and 30 control patients without inflammatory sinonasal pathology.
Research-Specific Interventions include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Characterize and compare patients with and without CRSwNP | Experimental | Experimental: Characterize and compare patients with and without CRSwNP Assessment of rheological and inflammatory variables |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sinonasal sample collection and inflammatory assessment | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 |
| Comparison of critical stress of sinonasal secretions |
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Inclusion Criteria:
Presence of nasal polyposis defined according to EPOS 2020 recommendations:
Clinical examination revealing, for at least 12 weeks prior to inclusion, 2 or more of the following symptoms:
Exclusion Criteria:
Inability to provide a sinonasal secretion sample by blowing
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valentin Favier, MD | Contact | 04 67 33 67 33 | 33 | v-favier@chu-montpellier.fr |
| Jérémy CHARRIOT | Contact | 04 67 33 59 37 | 33 | j-charriot@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Valentin FAVIER, MD | University Hospital, Montpellier | Principal Investigator |
| Jérémy CHARRIOT | University Hospital, Montpellier | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Montpellier | Montpellier | France |
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All study participants will get the same intervention but participants will be divided into two groups: with or without chronic rhinosinusitis with nasal polyps (CRSwNP).
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Measuring mucus critical stress (SigmaC) with the Rheomuco device. Comparison of viscosity between CRSwNP patients and a control group of patients without CRSwNP |
| Day 1 |
| 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. | Day 1 |
| Comparison of circulating eosinophilia | Measurement of blood eosinophil levels (absolute count in cells/mm3 and percentage). Comparison between CRSwNP patients and the control group. | Day 1 |
| Comparison of Fractional exhaled Nitric Oxide (FeNO) | Measurement of FeNO levels (in ppb) as a marker of airway inflammation. Comparison between the two study groups. | Day 1 |
| Comparison of clinical characteristics and quality of life using Sino-Nasal Outcome Test-22 questionnaire | Assessment of disease severity and quality of life using standardized questionnaire SNOT-22 (Sino-Nasal Outcome Test-22). The SNOT-22 is scored on a scale from 0 (no problem) to 5 (the most severe problem possible), with a total score ranging from 0 to 110 (higher scores indicate worse outcomes). | Day 1 |
| Comparison of clinical characteristics and quality of life using Dysfonctionnement Nasal Chronique questionnaire | Assessment of disease severity and quality of life using standardized questionnaire DyNaChron (Dysfonctionnement Nasal Chronique); It comprises 55 items divided into six symptom categories: nasal obstruction, anterior rhinorrhoea, posterior rhinorrhoea, smell disorders, facial pain/headaches, and chronic cough. The score ranges from 0 (no impact) to 550 (maximum impact). | Day 1 |
| Comparison of clinical characteristics and quality of life using Chronic Rhinosinusitis questionnaire | Assessment of disease severity and quality of life using standardized questionnaire CRSpro (Chronic Rhinosinusitis). The CRSpro questionnaire comprises 12 items divided into three categorizes: physical symptoms, sensory impairment and psychosocial effects. Each item is rated on a scale of 0 (not at all) to 4 (very much), and the total score ranges from 0 to 48. | Day 1 |
| Comparison of endoscopic severity (Nasal Polyp Score) | Evaluation of polyposis severity through endoscopic examination using the Nasal Polyp Score (scale 0 to 4). Nasal Polyp Score= 0: no polyps; 1: one polyp extending beyond the middle meatus; 2: two polyps extending beyond the middle meatus; 3: one polyp reaching the inferior turbinate; 4: one polyp extending beyond the inferior turbinate. | Day 1 |
| Association between local and systemic inflammation | Correlation analysis between tissue eosinophil counts (local) and circulating biomarkers (blood eosinophils, FeNO). | Day 1 |
| Association between rheological variables and inflammation | Correlation analysis between mucus rheological parameters (G', G'', sigma c) and local/systemic inflammatory markers. | Day 1 |
| Comparison of Lund-Mackay score | Evaluation of sinus disease severity using the Lund-Mackay score obtained from sinonasal computed tomography scans and comparison between CRSwNP patients and control patients. The Lund-Mackay scoring system based on sinonasal computed tomography (CT). Each paranasal sinus (maxillary, frontal, sphenoid, anterior ethmoid, posterior ethmoid) is scored as 0 = no abnormality, 1 = partial opacification, or 2 = complete opacification. The ostiomeatal complex is scored 0 = not obstructed or 2 = obstructed, with no intermediate value. The total score ranges from 0 to 24, with higher scores indicating more severe chronic rhinosinusitis. | Day 1 |
| CT mucus score | Evaluation of thoracic computed tomography findings using the CT mucus score and comparison between CRSwNP patients and control patients. The CT mucus score quantifies the burden of mucus plugs by counting the number of bronchopulmonary segments occluded by mucus on multidetector CT (MDCT). This system generates a quantitative score representing the extent of mucus impaction, with higher scores reflecting greater mucus plugging and more severe airway obstruction | Day 1 |
| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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