Development of endotype-based biomarkers to guide care for CRSwNP patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects data on inflammatory markers and disease burden in Greek adults with CRSwNP or CRSsNP. It aims to identify endotypes based on inflammatory profiles to better tailor future biologic therapies. No interventions are administered as part of the study; data collection informs endotype-based strategies. Participants may withdraw at any time, and data handling respects consent preferences. Data sources include clinical assessments and available tissue samples from prior or planned sinus surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Alexandroupoli, Greece Recruiting
• Research Site
  Athens, Greece Not yet recruiting
• Research Site
  Heraklion, Greece Not yet recruiting
• Research Site
  Thessaloniki, Greece Not yet recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.