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

21 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Osservativo

Iscrizione (Stimato)

230

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Grecia
      • Alexandroupoli, Grecia
        • Reclutamento
        • Research Site
      • Athens, Grecia
        • Non ancora reclutamento
        • Research Site
      • Heraklion, Grecia
        • Non ancora reclutamento
        • Research Site
      • Thessaloniki, Grecia
        • Non ancora reclutamento
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Prospective (CRSwNP)
CRSwNP patients who are scheduled to undergo first ESS (Endoscopic sinus surgery)
Altro: Not applicable - NIS study
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
Altro: Not applicable - NIS study
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
Altro: Not applicable - NIS study
Not applicable - NIS study

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Characterization of nasal tissue-secreted cytokines/chemokines in patients with CRSwNP
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
1i. Description of demographics of CRSwNP patients before and during 24 months after first endoscopic sinus surgery (ESS)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AstraZeneca

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

29 giugno 2026

Completamento primario (Stimato)

31 dicembre 2029

Completamento dello studio (Stimato)

31 dicembre 2029

Date di iscrizione allo studio

Primo inviato

18 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 giugno 2026

Primo Inserito (Effettivo)

23 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 luglio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • D5242R00007

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

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.

Periodo di condivisione IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Criteri di accesso alla condivisione IPD

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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