NCT07663409 The DEBATE Study "DEvelopment of Endotype-based Biomarkers for the Monitoring of Greek pATiEnts With CRSwNP"
| NCT ID | NCT07663409 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | CRSwNP or CRSsNP Patients |
| Study Type | OBSERVATIONAL |
| Enrollment | 230 participants |
| Start Date | 2026-06-29 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 230 participants in total. It began in 2026-06-29 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07663409 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CRSwNP or CRSsNP Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07663409 currently recruiting?
Yes, NCT07663409 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07663409 trial being conducted?
This trial is being conducted at Alexandroupoli, Greece, Athens, Greece, Heraklion, Greece, Thessaloniki, Greece.
Who is sponsoring the NCT07663409 clinical trial?
NCT07663409 is sponsored by AstraZeneca. The trial plans to enroll 230 participants.