The DEBATE Study "DEvelopment of Endotype-based Biomarkers for the Monitoring of Greek pATiEnts With CRSwNP" (DEBATE)
21 juillet 2026 mis à jour par: AstraZeneca
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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Observationnel
Inscription (Estimé)
230
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: AstraZeneca Clinical Study Information Center
- Numéro de téléphone: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Lieux d'étude
-
-
-
Alexandroupoli, Grèce
- Recrutement
- Research Site
-
Athens, Grèce
- Pas encore de recrutement
- Research Site
-
Heraklion, Grèce
- Pas encore de recrutement
- Research Site
-
Thessaloniki, Grèce
- Pas encore de recrutement
- Research Site
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
CRSwNP patients who are scheduled to undergo first ESS (prospective patients) will be recruited from approximately 6 Ear-Nose-Throat (ENT) and 1 pulmonology clinics.
Moreover, CRSwNP and CRSsNP patients who have already performed their first ESS in the period between 2012 and enrolment and have stored nasal tissue samples (retrospective patients) will be recruited from 1 ENT clinic.
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Prospective (CRSwNP)
CRSwNP patients who are scheduled to undergo first ESS (Endoscopic sinus surgery)
|
Not applicable - NIS study
|
|
Retrospective (CRSwNP)
CRSwNP patients who have already performed their first ESS in the period between 2012 and enrolment and have stored nasal tissue samples
|
Not applicable - NIS study
|
|
Retrospective (CRSsNP)
CRSsNP (Chronic rhinosinusitis without nasal polyps) patients who have already performed their first ESS in the period between 2012 and enrolment and have stored nasal tissue samples
|
Not applicable - NIS study
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Characterization of nasal tissue-secreted cytokines/chemokines in patients with CRSwNP
Délai: At Visit 1 (day 1)
|
Cytokine/chemokine analysis of the fresh extracted nasal tissue following first ESS will be performed by Luminex and ELISA analysis
|
At Visit 1 (day 1)
|
|
Characterization of nasal tissue immune cell populations in prospective patients with CRSwNP
Délai: At Visit 1 (day 1)
|
Immunophenotypic analysis by spectral flow cytometry of all main immune cell types, as well as detailed characterization of all T cell subsets will be performed in the fresh samples.
|
At Visit 1 (day 1)
|
|
Characterization of eosinophil and neutrophil cell counts in patients with CRSwNP
Délai: At Visit 1 (day 1)
|
Eosinophil and neutrophil cell counts will be recorded, as per the EPOS 2020, eosinophilia is defined as >10 eosinophils/hpf.
|
At Visit 1 (day 1)
|
|
Characterization of nasal histological alterations in retrospective patients with CRSwNP
Délai: At Visit 1 (day 1)
|
Tissue morphology and potential tissue destruction and nasal epithelium remodeling by standard histology staining (e.g.
hematoxylin and eosin, Periodic Acid-Schiff (PAS), and Sirius Red staining) will be assessed in stored nasal polyp tissue paraffin sections or paraffin blocks.
|
At Visit 1 (day 1)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
1i. Description of demographics of CRSwNP patients before and during 24 months after first endoscopic sinus surgery (ESS)
Délai: Up to 24 ± 2 months (through study completion)
|
Demographics at study entry/screening (age, sex, ethnicity, smoking status, cigarettes/day/year, alcohol status (units/week), body measurements (BMI kg/m2), employment status, educational level, residence area) will be recorded
|
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)
Délai: Up to 24 ± 2 months (through study completion)
|
Patients' medical history, including the date of first and severe CRSwNP diagnosis, comorbidities, and disease management [use (yes/no) of saline, systemic/local glucocorticoids, biologics, antibiotics], will be reported at the time of enrolment and during 24 months after first ESS.
|
Up to 24 ± 2 months (through study completion)
|
|
1i. Description of first ESS characteristics in CRSwNP patients
Délai: At Visit 1 (day 1)
|
Time to first ESS from CRSwNP diagnosis and from severe CRSwNP diagnosis will be assessed
|
At Visit 1 (day 1)
|
|
1ii. Assessment of 22-item Sinonasal Outcome Test (SNOT-22) score in CRSwNP patients
Délai: Up to 24 ± 2 months (through study completion)
|
The 22-item Sinonasal Outcome Test (SNOT-22), which is a health-related quality of life (HRQoL) evaluation with each item scored on a Likert scale ranging from 0 "No problem" to 5 "Problem as bad as it can be".
|
Up to 24 ± 2 months (through study completion)
|
|
1ii. Assessment of The Nasal Polyposis Symptom Diary (NPSD) in CRSwNP patients
Délai: Up to 24 ± 2 months (through study completion)
|
The Nasal Polyposis Symptom Diary (NPSD), which is a short patient-reported outcome (PRO) tool comprising 11 items (8 symptom-specific, 2 symptom-impact, and 1 optional medication-compliance).
The Total Symptom Score (TSS) is a summary of the first 8 symptom-specific items, scored on a 4-point scale [0-none, 1-mild, 2-moderate, 3-severe], with a resulting score from 0 to 24
|
Up to 24 ± 2 months (through study completion)
|
|
1ii. Assessment of the Asthma Control Test (ACT) in CRSwNP patients (if comorbidity with asthma)
Délai: Up to 24 ± 2 months (through study completion)
|
The Asthma Control Test (ACT), a patient-based tool for identifying patients with poorly controlled asthma that includes 5 items assessing the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control.
The ACT responses for each of the items are summed to yield a score ranging from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control.
|
Up to 24 ± 2 months (through study completion)
|
|
1iii. Assessment of Nasal Polyps Score (NPS) score in CRSwNP patients
Délai: Up to 6 months before Visit 1 (day 1) & at Visit 2 (24 ± 2 months)
|
NPS is a physician-reported tool that grades the extent/severity of nasal polyps based on evaluation by nasal endoscopy.
Each nostril is scored on a scale of 0 - "No nasal polyps" to 4 - "Large nasal polyps causing complete obstruction of the inferior nasal cavity", with the total score being the sum of left and right nostril scores (range: 0-8).
|
Up to 6 months before Visit 1 (day 1) & at Visit 2 (24 ± 2 months)
|
|
1iii. Assessment of imaging results in CRSwNP patients
Délai: Up to 6 months before Visit 1 (day 1) & at Visit 2 (24 ± 2 months)
|
The Lund-Mackay (LM) CT score that evaluates sinus opacification on CT scans.
This score ranges from 0 -"complete lucency of all sinuses" to 24 - "complete opacity of all sinuses"
|
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
Délai: At Visit 1 (day 1)
|
Cytokine/chemokine analysis of blood samples following first ESS will be performed by Luminex and ELISA analysis
|
At Visit 1 (day 1)
|
|
2. Characterization of blood immune cell populations in prospective patients with CRSwNP
Délai: At Visit 1 (day 1)
|
Immunophenotypic analysis by spectral flow cytometry of all main immune cell types, as well as detailed characterization of all T cell subsets will be performed in the fresh samples.
|
At Visit 1 (day 1)
|
|
2. Characterization of serum immunoglobulin levels in prospective patients with CRSwNP
Délai: At Visit 1 (day 1)
|
Serum immunoglobulin levels [total IgE, specific IgE to staphylococcal enterotoxins (SE-IgE)]
|
At Visit 1 (day 1)
|
|
2. Characterization of WBC count in prospective patients with CRSwNP
Délai: At Visit 1 (day 1)
|
Differential WBC count (incl.
absolute count) will be recorded
|
At Visit 1 (day 1)
|
|
2. Characterization of RBC count in prospective patients with CRSwNP
Délai: At Visit 1 (day 1)
|
RBC count will be recorded
|
At Visit 1 (day 1)
|
|
3. Association of time to CRSwNP recurrence and CRSwNP endotypes over 24 months following first ESS in CRSwNP patients
Délai: Up to 24 ± 2 months (through study completion)
|
The number of CRSwNP recurrences along with the date(s) of recurrence(s) will be recorded in the eCRF by the investigator at 24 months following first ESS for CRSwNP patients (including retrospective CRSwNP patients, if data are available).
The time to relapse during the 24-month follow-up will be also estimated.
|
Up to 24 ± 2 months (through study completion)
|
|
4. Differences in cytokine/chemokine levels between retrospective patients with CRSwNP and CRSsNP
Délai: At Visit 1 (day 1)
|
Endotypes of CRSsNP patients who have performed first ESS in the period between 2012 and enrolment (retrospective patients) will be determined based on cytokine/chemokine analysis of frozen extracted nasal tissue from ESS, including Fractalkine, GM-CSF, IFNγ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, (p70), IL-13, IL-17A, IL-21, IL-23, ITAC, MIP-1α, MIP-1β, MIP-3α, TNF-α, TSLP, IL-9, IL-33, IL-17E/IL-25, TGFb1, IL-22
|
At Visit 1 (day 1)
|
|
4. Differences in eosinophil and neutrophil cell counts between retrospective patients with CRSwNP and CRSsNP
Délai: At Visit 1 (day 1)
|
Eosinophil and neutrophil cell counts will be recorded.
As per the EPOS 2020, eosinophilia is defined as >10 eosinophils/hpf
|
At Visit 1 (day 1)
|
|
4. Differences in nasal tissue alterations between retrospective patients with CRSwNP and CRSsNP
Délai: At Visit 1 (day 1)
|
tissue morphology and potential nasal tissue destruction and remodeling by standard histology staining (e.g.
Hematoxylin and eosin, Periodic acid-Schiff (PAS), and Sirius Red staining) will be assessed in stored nasal polyp tissue paraffin sections or paraffin blocks.
Depending on the nature of tissue pathology, further immunohistochemical analysis will be performed with the use of specific antibodies, such as markers for epithelial barrier integrity (e.g.
E-cadherin or Cytokeratin), tissue remodeling (e.g.
MMP-9) or chronic damage monitored by fibrosis (e.g.
α-SMA or collagen)
|
At Visit 1 (day 1)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
29 juin 2026
Achèvement primaire (Estimé)
31 décembre 2029
Achèvement de l'étude (Estimé)
31 décembre 2029
Dates d'inscription aux études
Première soumission
18 mai 2026
Première soumission répondant aux critères de contrôle qualité
17 juin 2026
Première publication (Réel)
23 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 juillet 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- D5242R00007
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All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Délai de partage IPD
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For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Critères d'accès au partage IPD
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Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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Type d'informations de prise en charge du partage d'IPD
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Informations sur les médicaments et les dispositifs, documents d'étude
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Non
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