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

Overview

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.

Detailed description

A participant may withdraw from the study at any time at the participant's own request for any reason (or without providing any reason) without any implication on participant's rights. Patients who discontinue should be asked about the reason(s) for their discontinuation. If the participant withdraws consent for disclosure of future information, AstraZeneca may retain and continue to use any data collected before such a withdrawal of consent

Interventions

• Other Not applicable - NIS study
  Not applicable - NIS study

Primary outcome measures

• Characterization of nasal tissue-secreted cytokines/chemokines in patients with CRSwNP [Time frame: At Visit 1 (day 1)]
• Characterization of nasal tissue immune cell populations in prospective patients with CRSwNP [Time frame: At Visit 1 (day 1)]
• Characterization of eosinophil and neutrophil cell counts in patients with CRSwNP [Time frame: At Visit 1 (day 1)]
• Characterization of nasal histological alterations in retrospective patients with CRSwNP [Time frame: At Visit 1 (day 1)]

Secondary outcome measures (12)

• 1i. Description of demographics of CRSwNP patients before and during 24 months after first endoscopic sinus surgery (ESS) [Time frame: Up to 24 ± 2 months (through study completion)]
• 1i. Description of medical history of CRSwNP patients before and during 24 months after first endoscopic sinus surgery (ESS) [Time frame: Up to 24 ± 2 months (through study completion)]
• 1i. Description of first ESS characteristics in CRSwNP patients [Time frame: At Visit 1 (day 1)]
• 1ii. Assessment of 22-item Sinonasal Outcome Test (SNOT-22) score in CRSwNP patients [Time frame: Up to 24 ± 2 months (through study completion)]
• 1ii. Assessment of The Nasal Polyposis Symptom Diary (NPSD) in CRSwNP patients [Time frame: Up to 24 ± 2 months (through study completion)]
• 1ii. Assessment of the Asthma Control Test (ACT) in CRSwNP patients (if comorbidity with asthma) [Time frame: Up to 24 ± 2 months (through study completion)]
• 1iii. Assessment of Nasal Polyps Score (NPS) score in CRSwNP patients [Time frame: Up to 6 months before Visit 1 (day 1) & at Visit 2 (24 ± 2 months)]
• 1iii. Assessment of imaging results in CRSwNP patients [Time frame: Up to 6 months before Visit 1 (day 1) & at Visit 2 (24 ± 2 months)]
• 2. Characterization of blood cytokines/chemokines in prospective patients with CRSwNP [Time frame: At Visit 1 (day 1)]
• 2. Characterization of blood immune cell populations in prospective patients with CRSwNP [Time frame: At Visit 1 (day 1)]
• 2. Characterization of serum immunoglobulin levels in prospective patients with CRSwNP [Time frame: At Visit 1 (day 1)]
• 2. Characterization of WBC count in prospective patients with CRSwNP [Time frame: At Visit 1 (day 1)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Greece · 4 centers

• Research Site — Alexandroupoli
• Research Site — Athens
• Research Site — Heraklion
• Research Site — Thessaloniki

Identifiers

NCT: NCT07663409 · D5242R00007

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗