Clinical trial NCT06815211: The German National CRS Registry (GenreCRS): Clinical Evaluation of the New European Academy for Allergy and Clinical Immunology (EAACI) Criteria for CRSwNP Disease Control, Remission and Cure in a Real-World Evidence Study Approach
Official title: A Prospective Study for Real-world Evaluation of the Novel European Academy for Allergy and Clinical Immunology (EAACI) Criteria for Disease Control, Remission and Cure in CRSwNP Utilizing the German National CRS Registry (GENRE CRS)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Rhinosinusitis (CRS)
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Keywords: CRSwNP
CRSsNP
Nasal Polyps
Registry
Patient Reported Outcome Measures (PROM)
Lead sponsor: Ärzteverband Deutscher Allergologen e.V.
Sponsor class: OTHER
Collaborators: name: German Society of Otorhinolaryngology, Head and Neck Surgery
First posted: 2025-02-07
Enrollment: 500
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients above the age of 18 years of any gender with the diagnosis of CRSwNP and CRSsNP treated by a specialized treatment centre in Germany that is part of the German CRS registry network will be included in the study.

Brief summary: The objective of the study is to establish a registry of patients diagnosed with Chronic Rhinosinusitis with and without Nasal Polyps (CRSwNP/CRSsNP) to collect comprehensive longitudinal real-world evidence from specialised treatment centres in Germany. The primary analysis will concentrate on the treatment efficacy and safety of biologic drugs with a focus on defining disease Control, Remission, and Cure as well as to validate the corresponding clinical evaluation criteria.

Detailed description: The German national CRS registry (Genre CRS) is a nationwide registry for patients with CRSsNP and CRSwNP that aims to include more than 250 centres in Germany. Genre CRS is operated by the German Societies of Allergology (AeDA) and Otorhinolaryngology (DGHNO) and is based on most advanced digital health technologies, including a wide variety of collected parameters. Additionally, patient-reported outcome measures will be captured via a smart phone app and submitted directly to the registry database. This registry is the first of its kind in Germany. It will be the foundation for answering many critical/pivotal research questions that depend on high quality, extensive longitudinal data provided by the registry for future studies.

One important field of application will be the long-term assessment of RWE on therapeutic antibodies, also known as "biologics". Biologics are a novel treatment option for patients with severe CRSwNP and have led to tremendous treatment success. Chronically ill patients with a long history of severe symptoms and impaired quality of life can now experience a significant improvement in CRSwNP symptoms when treated with a biologic, which has prompted the discussion about disease Control, Remission, and even Cure. So far, internationally accepted and clinically evaluated definitions of these terms are lacking, but would greatly assist clinicians in developing therapeutic strategies, particularly for the long-term management of chronically affected patients. The criteria currently in use, although generally accepted, are not evidence-based and do not reflect the perspectives of patients and healthcare providers. An international expert working group of the European Academy for Allergy and Clinical Immunology (EAACI) has therefore developed such criteria, which now need to be clinically evaluated and validated using the comprehensive longitudinal data from Genre CRS.

Data collection includes a variety of parameters involved in the treatment with biologics, analysis of their long-term efficacy and safety including but not limited to:

* Polyp Size
* SNOT22
* Visual analog scales for nasal congestion, rhinorrhea, pressure/facial pain, sense of smell
* Olfactory function
* Necessity for rescue treatment (sinus surgery, OCS)
* Parameters of co-morbid diseases
* Type 2 biomarkers

Eligibility criteria: Inclusion Criteria:

* Patients above the age of 12 years
* Patients who are diagnosed with CRS according to internationally valid guidelines (EPOS 2020)
* Patients who provide written informed consent or by a legal representative

Exclusion Criteria:

* Patients below the age of 12 years at initiation
* Patients who do not provide written consent or withdraw their consent

Primary outcomes:
measure: Nasal Polyp Score
timeFrame: 1 year
measure: University of Pennsylvania Smell Identification Test (UPSIT)
timeFrame: 1 year
measure: Sniffin' Sticks Identification Test 12
timeFrame: 1 year
measure: Sniffin' Sticks Identification Test 16
timeFrame: 1 year
measure: Sinonasal Outcome Test 22 (SNOT22)
timeFrame: 1 year
measure: Rescue Treatment
timeFrame: 1 year
Secondary outcomes:
measure: Peak Nasal Inspiratory Flow (PNIF)
timeFrame: 1 year
measure: Blood eosinophils
timeFrame: 1 year
measure: Lund-Mackay Score
timeFrame: 1 year
measure: Allergic Rhinitis Visual Analogue Scale (AR-VAS)
timeFrame: 1 year
measure: Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: 1 year
measure: Fractional exhaled nitric oxide (FeNO)
timeFrame: 1 year
measure: Immunoglobulin E (IgE)
timeFrame: 1 year
Other outcomes:
Locations:
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