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The DEBATE Study "DEvelopment of Endotype-based Biomarkers for the Monitoring of Greek pATiEnts With CRSwNP"

RecruitingN/A

Sponsor: AstraZeneca

Conditions: CRSwNP or CRSsNP Patients

Interventions: Not applicable - NIS study

Countries: Greece

Given the high variability in the inflammatory profiles of CRSwNP (Chronic rhinosinusitis with nasal polyps) patients that influence both disease phenotype and response to treatment, exploring further potential targets is crucial for advancing novel biologic treatment strategies. By indicating the efficacy of targeted therapy, as well as determining clinical features, endotyping of CRSwNP may offer a useful tool to better tailor treatment approaches in this heterogenous patient population. This study is the first national effort to collect data on inflammatory markers and burden of CRSwNP patients in Greece aiming at identifying disease endotypes based on patients' inflammatory profile.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years
* If CRSwNP group:

Physician-diagnosed severe, uncontrolled CRSwNP according to the EUFOREA/EPOS 2020 and ICAR-RS 2021 guidelines with:

* CRSwNP severity consistent with the need for surgery as defined by a total nasal polyp score (NPS) of ≥5 (≥2 for each nostril)
* Nasal Congestion Score (NCS) of ≥2
* Ongoing documented symptoms of CRSwNP for \> 8 weeks before surgery

If CRSsNP group:

Diagnosis of CRSsNP according to the EUFOREA/EPOS 2020 and ICAR-RS 2021 guidelines

* Have performed in the period between 2012 and enrolment or are scheduled to perform endoscopic sinus surgery (ESS) for the first time at enrolment
* Have available nasal polyp tissue sample from the first endoscopic sinus surgery (ESS)
* Have provided signed and dated written informed consent
* If CRSwNP group:

Patients receiving any standard of care treatment for CRSwNP, provided the participant is stable on that treatment for ≥30 days

Exclusion Criteria:

* Patients with cystic fibrosis or immunodeficiency
* Presence of acute exacerbation of CRS symptoms within 2 weeks prior to surgery
* Use of systemic corticosteroids within 30 days prior to surgery, or antileukotrienes within 15 days prior to surgery, or biologic therapy prior to surgery
* Not adequate amount (\<0.15g) or quality (e.g. storage temperature, contamination) of tissue sample for analyses
* Not available blood (serum) sample, only for patients scheduled to perform endoscopic sinus surgery (ESS) for the first time at the date of enrolment, for analyses.

Locations (4)

Alexandroupoli, Greece
Athens, Greece
Heraklion, Greece
Thessaloniki, Greece