Anatomo-clinico-biological Profiles in Severe Nasal Polyps
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Evaluation of symptoms related to nasal sinus polyposis by visual analogue scale
研究概览
简要总结
Nasal sinus polyposis is a chronic inflammatory pathology of the nasal cavity and sinus cavities that causes bilateral and multifocal polyp development and has a prevalence of 2 to 4% in the general population.
Therapeutic management consists of first-line medical treatment for anti-inflammatory purposes. Local corticosteroid therapy, using nasal sprays, is the background treatment. Surgical management is offered to patients in case of failure of medical treatment. Although effective, surgery does not protect patients from recurrence of symptoms related to regrowth of polyps. Recently, biologics have appeared, which despite its effectiveness, about 20% of patients have a partial or no response to these treatments. There is currently no possibility of determining the probability of response to treatments in patients.
It is therefore essential to determine an anatomo-clinico-biological correlation associating the anatomopathological profile, the clinical characteristics and the cytokine signature in order to best guide the patient's management, including the initiation of biotherapy. Indeed, patients, according to their clinical, biological characteristics and the cytokine signature of their polyps will react differently to different treatments, including surgery and biotherapy. This correlation will serve as a predictor of treatment response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 18 year-old
- •Patient with nasal sinus polyposis resistant to medical treatment and requiring surgical treatment with ethmoidectomy type is considered for the first time
- •Having signed the consent form
- •Having an health insurance
排除标准
- •Current or past biotherapy treatment
- •Taking general corticosteroid therapy within 4 weeks of surgery
- •Protected person
- •Pregnant women or lactating women
结局指标
主要结局
Evaluation of symptoms related to nasal sinus polyposis by visual analogue scale
时间窗: 1 day
the measurement by the visual analogue scale (ranging from 0 (no) to 10 (very intense)
Identify anatomical profiles present in nasal sinus polyposis resistant to medical treatment.
时间窗: 1 day
Caracterization the profiles of patients by the presence or not of edematous or fibrous component, infiltration and lymphoplasmocytic infiltrates.
Evaluation to cytokine concentration in serum for patients with nasal sinus polyposis
时间窗: 1 day
The measurement to cytokine concentration in serum (mg/l)
Identify biological profiles for patients with nasal sinus polyposis
时间窗: 1 day
The measurement to cytokine expression of naso-sinus polyps (RNA sequencing analysis)
Evaluation to quality of life by Sino-Nasal Outcome Test
时间窗: 1 day
the measurement to quality of life by Sino-Nasal Outcome Test (test SNOT-22: test is a questionnaire that reviews 22 symptoms. Each item quantifies the severity of the symptom from 0 (no problem) to 5 (very severe problem). The maximum score is 110, a high score indicating a significant impact of symptoms).
次要结局
未报告次要终点