Chronic rhinosinusitis and nasal polyposis a GA2LEN cohort study

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 125

Inclusion Criteria

1. The subject understands the study procedures and agrees to participate by signing the consent form.
2. The subject is male or female, at least 18 years of age but no more than 60 years of age
3. Subjects must be in good health, free of any clinically significant disease that would interfere with the study or procedures or compromise his/her safety.
4.Diagnosis of chronic rhinosinusitis:
The diagnosis of chronic rhinosinusitis (with or without nasal polyps, including fungal disease, Cystic fibrosis, etc.) based on the EP3OS definition ;For controls: Controls are patients undergoing surgery such as septoplasty or septorhinoplasty, who have no medical history or symptoms of any form of chronic rhinosinusitis

Exclusion Criteria

1. Patients with a recent acute exacerbation of rhinosinusitis (past two weeks) are not allowed to participate
2. The subject had functional endoscopic sinus surgery (FESS) before, with removal of parts of the lateral nasal wall. Polypectomy, septal or inferior turbinate surgery is allowed.
3. Women must not be pregnant or breast feeding
4. The subject is a current or recent past abuser of alcohol or illicit drugs
5. The subject has a history of malignancy, is known to be positive for HIV, has immunodeficiencies or other states that are considered to interfere with study conduct or scientific interpretations.
6. Subjects must not be known to have sarcoidosis
7. Subjects must not be known to have any type of vasculitis (including Wegener)
8. Subjects must not be known to be positive to hepatitis B surface antigen or C antibodies.
9. The subject cannot read or comprehend written material, or is in the opinion of the investigator, for other reasons unlikely to understand and follow the study procedures.
10. The subject is mentally or legally incapacitated preventing informed consent from being obtained.
11. Medication: For Visit 2 a wash-out period for the medications (oral steroids 4 weeks, Nasal steroids 2 weeks, anti-leukotrienes 2 weeks) is mandatory, for visit 1 the wash-out period is advisable although patients using this medication can be included.
12. Inhalation steroids for asthma are permitted but should be documented in the questionnaires.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Characterization and further differentiation of chronic sinus disease based on<br /><br>clinical and biological parameters.<br /><br><br /><br>The following inflammation parameters will be particularly analyzed:<br /><br><br /><br>A) Immunohistochemical staining for eosinophils (H&E ), neutrophils (H&E, MPO),<br /><br>macrophages, T-cells, B-cells (frozen sections)<br /><br><br /><br>B) On tissue homogenates:<br /><br>* Pro-inflammatory cytokines: IL-1, TNF-<br /><br>* Eosinophilic inflammation: ECP, eotaxin, IgE<br /><br>* Neutrophilic inflammation: IL-8, MPO<br /><br>* T cell markers: sIL-2R, IFN-(Th1), IL-5(Th2)<br /><br>* TGF-beta 1<br /><br><br /><br>C) On nasal secretions:<br /><br>* ECP<br /><br>* TGF-beta<br /><br>* IgE<br /><br>* Il-1beta<br /><br>* TNFalpha<br /><br>* Il8<br /><br>* Il5? NP<br /><br>* MPO<br /><br><br /><br>D) Full blood and eosinophil count</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(1) Determine T-cells scources for Th1 cytokines (INF-g), Th2 cytokines (IL-4<br /><br>and IL-5, and T regulatory asscoiated expression of CD25, foxP3, IL-10, and<br /><br>TGF-b.<br /><br>(2) Determine activation status of blood born T regulatory cells </p><br>