The DEBATE Study "DEvelopment of Endotype-based Biomarkers for the Monitoring of Greek pATiEnts With CRSwNP" (DEBATE)
21 de julio de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
De observación
Inscripción (Estimado)
230
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: AstraZeneca Clinical Study Information Center
- Número de teléfono: 1-877-240-9479
- Correo electrónico: information.center@astrazeneca.com
Ubicaciones de estudio
-
-
-
Alexandroupoli, Grecia
- Reclutamiento
- Research Site
-
Athens, Grecia
- Aún no reclutando
- Research Site
-
Heraklion, Grecia
- Aún no reclutando
- Research Site
-
Thessaloniki, Grecia
- Aún no reclutando
- Research Site
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Characterization of nasal tissue-secreted cytokines/chemokines in patients with CRSwNP
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
1i. Description of demographics of CRSwNP patients before and during 24 months after first endoscopic sinus surgery (ESS)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
29 de junio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2029
Finalización del estudio (Estimado)
31 de diciembre de 2029
Fechas de registro del estudio
Enviado por primera vez
18 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de junio de 2026
Publicado por primera vez (Actual)
23 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de julio de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- D5242R00007
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir 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.
Criterios de acceso compartido de 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 información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .