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

NCT ID: NCT06815211

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2028-10-31

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

Conditions

Chronic Rhinosinusitis (CRS); Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

sinus surgery

all patients who received sinus surgery during the observation period

No interventions assigned to this group

biologic treatment

all patients who are treated with a biologic drug

No interventions assigned to this group

non-biologic, non-surgery

all patients without surgery or biologic treatment during observation period

No interventions assigned to this group

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Society of Otorhinolaryngology, Head and Neck Surgery

UNKNOWN

Sponsor Role: collaborator

Ärzteverband Deutscher Allergologen e.V.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jan Hagemann, Dr. med.

Role: CONTACT

jan.hagemann@allergiezentrum.org

+49611308608273

Friederike Bärhold, Dr. med.

Role: CONTACT

friederike.baerhold@allergiezentrum.org

+49611308608273

Other Identifiers

GenreCRS_2024_V1.0

Identifier Type: -

Identifier Source: org_study_id