The DEBATE Study "DEvelopment of Endotype-based Biomarkers for the Monitoring of Greek pATiEnts W… (NCT07663409) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The DEBATE Study "DEvelopment of Endotype-based Biomarkers for the Monitoring of Greek pATiEnts With CRSwNP"
230 participantsStarted 2026-06-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Characterization of nasal tissue-secreted cytokines/chemokines in patients with CRSwNP
Timeframe: At Visit 1 (day 1)
2
Characterization of nasal tissue immune cell populations in prospective patients with CRSwNP
Timeframe: At Visit 1 (day 1)
3
Characterization of eosinophil and neutrophil cell counts in patients with CRSwNP
Timeframe: At Visit 1 (day 1)
4
Characterization of nasal histological alterations in retrospective patients with CRSwNP