The DEBATE Study "DEvelopment of Endotype-based Biomarkers for the Monitoring of Greek pATiEnts With CRSwNP" (DEBATE)
2026년 7월 21일 업데이트: 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.
연구 개요
상세 설명
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
연구 유형
관찰
등록 (추정된)
230
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: AstraZeneca Clinical Study Information Center
- 전화번호: 1-877-240-9479
- 이메일: information.center@astrazeneca.com
연구 장소
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Alexandroupoli, 그리스
- 모병
- Research Site
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Athens, 그리스
- 아직 모집하지 않음
- Research Site
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Heraklion, 그리스
- 아직 모집하지 않음
- Research Site
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Thessaloniki, 그리스
- 아직 모집하지 않음
- Research Site
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Prospective (CRSwNP)
CRSwNP patients who are scheduled to undergo first ESS (Endoscopic sinus surgery)
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Not applicable - NIS study
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Retrospective (CRSwNP)
CRSwNP patients who have already performed their first ESS in the period between 2012 and enrolment and have stored nasal tissue samples
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Not applicable - NIS study
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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
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Not applicable - NIS study
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Characterization of nasal tissue-secreted cytokines/chemokines in patients with CRSwNP
기간: At Visit 1 (day 1)
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Cytokine/chemokine analysis of the fresh extracted nasal tissue following first ESS will be performed by Luminex and ELISA analysis
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At Visit 1 (day 1)
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Characterization of nasal tissue immune cell populations in prospective patients with CRSwNP
기간: 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
기간: 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
기간: 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.
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At Visit 1 (day 1)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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1i. Description of demographics of CRSwNP patients before and during 24 months after first endoscopic sinus surgery (ESS)
기간: Up to 24 ± 2 months (through study completion)
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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
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Up to 24 ± 2 months (through study completion)
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1i. Description of medical history of CRSwNP patients before and during 24 months after first endoscopic sinus surgery (ESS)
기간: Up to 24 ± 2 months (through study completion)
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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.
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Up to 24 ± 2 months (through study completion)
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1i. Description of first ESS characteristics in CRSwNP patients
기간: At Visit 1 (day 1)
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Time to first ESS from CRSwNP diagnosis and from severe CRSwNP diagnosis will be assessed
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At Visit 1 (day 1)
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1ii. Assessment of 22-item Sinonasal Outcome Test (SNOT-22) score in CRSwNP patients
기간: Up to 24 ± 2 months (through study completion)
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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".
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Up to 24 ± 2 months (through study completion)
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1ii. Assessment of The Nasal Polyposis Symptom Diary (NPSD) in CRSwNP patients
기간: Up to 24 ± 2 months (through study completion)
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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
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Up to 24 ± 2 months (through study completion)
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1ii. Assessment of the Asthma Control Test (ACT) in CRSwNP patients (if comorbidity with asthma)
기간: Up to 24 ± 2 months (through study completion)
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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.
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Up to 24 ± 2 months (through study completion)
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1iii. Assessment of Nasal Polyps Score (NPS) score in CRSwNP patients
기간: 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).
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Up to 6 months before Visit 1 (day 1) & at Visit 2 (24 ± 2 months)
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1iii. Assessment of imaging results in CRSwNP patients
기간: Up to 6 months before Visit 1 (day 1) & at Visit 2 (24 ± 2 months)
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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"
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Up to 6 months before Visit 1 (day 1) & at Visit 2 (24 ± 2 months)
|
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2. Characterization of blood cytokines/chemokines in prospective patients with CRSwNP
기간: 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
기간: 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
기간: At Visit 1 (day 1)
|
Serum immunoglobulin levels [total IgE, specific IgE to staphylococcal enterotoxins (SE-IgE)]
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At Visit 1 (day 1)
|
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2. Characterization of WBC count in prospective patients with CRSwNP
기간: At Visit 1 (day 1)
|
Differential WBC count (incl.
absolute count) will be recorded
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At Visit 1 (day 1)
|
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2. Characterization of RBC count in prospective patients with CRSwNP
기간: At Visit 1 (day 1)
|
RBC count will be recorded
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At Visit 1 (day 1)
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3. Association of time to CRSwNP recurrence and CRSwNP endotypes over 24 months following first ESS in CRSwNP patients
기간: 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)
|
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4. Differences in cytokine/chemokine levels between retrospective patients with CRSwNP and CRSsNP
기간: 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
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At Visit 1 (day 1)
|
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4. Differences in eosinophil and neutrophil cell counts between retrospective patients with CRSwNP and CRSsNP
기간: 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
기간: 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)
|
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 6월 29일
기본 완료 (추정된)
2029년 12월 31일
연구 완료 (추정된)
2029년 12월 31일
연구 등록 날짜
최초 제출
2026년 5월 18일
QC 기준을 충족하는 최초 제출
2026년 6월 17일
처음 게시됨 (실제)
2026년 6월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 21일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- D5242R00007
개별 참가자 데이터(IPD) 계획
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IPD 계획 설명
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IPD 공유 기간
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For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD 공유 액세스 기준
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IPD 공유 지원 정보 유형
- 연구_프로토콜
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