Phenotyping of Type 2 Inflammation Profile by Rheology of Nasal Secretions and Tissue Quantification of Eosinophilic Polymorphonuclear Cells in the Middle Turbinate
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparison of viscosity of sinonasal secretions
研究概览
简要总结
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.
详细描述
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:
- Rheology Analysis: Nasal secretions are collected by blowing onto an aluminum plate. Viscosity (G'), elasticity (G'), and critical stress (sigma c) are measured using the Rheomuco® device at 37°C.
- Histology: Intraoperative biopsies of the middle turbinate are performed to quantify tissue eosinophils through serialized HE staining and immunolabeling (EPX, IL-5 receptor).
- Blood Collection: An additional 7 mL EDTA tube is collected to create a serum bank for ancillary studies of Type 2 cytokines (IL-5, IL-13).
- Clinical Correlation: Data are correlated with clinical scores (SNOT-22), sinonasal CT scans, and respiratory function tests (FeNO, spirometry) to evaluate the link between local tissue inflammation and systemic profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requiring sinonasal surgery
- •For patients in the CRSwNP group:
- •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:
- •Nasal congestion
- •Rhinorrhea (anterior/posterior)
- •Or a Facial pain/pressure
- •Or a Reduced or lost sense of smell AND visible polyps in both nasal cavities on endoscopic examination of the middle meatus (regardless of size).
排除标准
- •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
- •Legal protection status (guardianship, curatorship, etc.)
- •No social security coverage
- •Persons deprived of liberty by judicial or administrative decision
- •Participation in another study with an ongoing exclusion period
研究组 & 干预措施
Characterize and compare patients with and without CRSwNP
Experimental: Characterize and compare patients with and without CRSwNP Assessment of rheological and inflammatory variables
干预措施: Sinonasal sample collection and inflammatory assessment (Procedure)
结局指标
主要结局
Comparison of viscosity of sinonasal secretions
时间窗: Day 1
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
次要结局
- Comparison of elasticity (G' [Pa]) of sinonasal secretions(Day 1)
- Comparison of critical stress of sinonasal secretions(Day 1)
- Comparison of tissue eosinophilia(Day 1)
- Comparison of circulating eosinophilia(Day 1)
- Comparison of Fractional exhaled Nitric Oxide (FeNO)(Day 1)
- Comparison of clinical characteristics and quality of life using Sino-Nasal Outcome Test-22 questionnaire(Day 1)
- Comparison of clinical characteristics and quality of life using Dysfonctionnement Nasal Chronique questionnaire(Day 1)
- Comparison of clinical characteristics and quality of life using Chronic Rhinosinusitis questionnaire(Day 1)
- Comparison of endoscopic severity (Nasal Polyp Score)(Day 1)
- Association between local and systemic inflammation(Day 1)
- Association between rheological variables and inflammation(Day 1)
- Comparison of Lund-Mackay score(Day 1)
- CT mucus score(Day 1)