The DEBATE Study "DEvelopment of Endotype-based Biomarkers for the Monitoring of Greek pATiEnts With CRSwNP" (DEBATE)
21 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Observacional
Inscrição (Estimado)
230
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: AstraZeneca Clinical Study Information Center
- Número de telefone: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Locais de estudo
-
-
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Alexandroupoli, Grécia
- Recrutamento
- Research Site
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Athens, Grécia
- Ainda não está recrutando
- Research Site
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Heraklion, Grécia
- Ainda não está recrutando
- Research Site
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Thessaloniki, Grécia
- Ainda não está recrutando
- Research Site
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Characterization of nasal tissue-secreted cytokines/chemokines in patients with CRSwNP
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
1i. Description of demographics of CRSwNP patients before and during 24 months after first endoscopic sinus surgery (ESS)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
29 de junho de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2029
Conclusão do estudo (Estimado)
31 de dezembro de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
18 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de junho de 2026
Primeira postagem (Real)
23 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
22 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de julho de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- D5242R00007
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de 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.
Critérios de acesso de compartilhamento 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 de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .