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NCT06970977Recruiting

CRS Questionnaire Validation Project

The European Forum for Research and Education in Allergy and Airway Diseases

Start Date

9/1/2024

Completion Date

9/30/2026

Summary

The 'CRS validation project' consists of a joint effort of 32 medical centers in Europe, the USA, and South Africa to carry out the validation of 2 novel questionnaires designated to measure self-perceived severity and control of Chronic Rhinosinusitis (with or without nasal polyps). This study will validate translated versions of the same set of questionnaires simultaneously in the centers involved after recruiting a total of 1000 patients, while data collection, statistical analysis, and creation of the study report will be carried out by the statistical department of the University of Leuven. Patients will be recruited from the regular ENT practice of their hospital to minimize the complexity of the study.

Detailed Description

The objectives of this study are as follows: * Validation of two new questionnaires with the aim of measuring the current perceived condition of a patient with chronic rhinosinusitis in terms of control and severity. * Validation of these questionnaires in routine medical settings. * Evaluation of the results of these questionnaires in comparison with other tools currently available.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Patient capable of giving informed consent * Diagnosis of chronic rhinosinusitis with or without nasal polyposis according to the EPOS guidelines * No recent sinus surgery (within the last three months) Exclusion Criteria: * Not capable of giving informed consent * No CRS * Recent sinus surgery (within the last three months)

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Conditions

Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Locations

UCLA Santa Monica Medical Center

Santa Monica, California 90401

United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois 60208

United States

Brigham Sinus Center at Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania 19107

United States

Eastern Virginia Medical School

Virginia City, Virginia 23507

United States

UZ Gent

Ghent,

Belgium

UZ Leuven

Leuven,

Belgium

St. Michael's Hospital

Toronto,

Canada

Univ of Copenhagen

Copenhagen,

Denmark

HNO-Klinik, Universitätsklinikum Düsseldorf

Düsseldorf,

Germany

Univ Munich

Munich,

Germany

University General Hospital of Heraklion

Heraklion,

Greece

U. Aristotle

Thessaloniki,

Greece

Univ Hospital Roma

Roma,

Italy

Univ Amsterdam

Amsterdam,

Netherlands

Alrijne Zorggroep

Leiden,

Netherlands

University of Oradea

Oradea,

Romania

Ahmed Alkhadi Hospital

Durban,

South Africa

Hospital Clínico Universitario de Compostela

A Coruña,

Spain

Hospital Clinic Barcelona

Barcelona,

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona,

Spain

Hospital de La Línea de La Concepción

Cadiz,

Spain

Hospital Universitario Jerez de La Frontera

Cadiz,

Spain

Hospital Universitario Puerta del Mar

Cadiz,

Spain

Hospital Universitario Puerto Real

Cadiz,

Spain

Hospital Universitario Fuenlabrada

Madrid,

Spain

Hospital Universitario Infanta Elena, Madrid y Hospital Universitario Fundación Jiménez Díaz

Madrid,

Spain

Hospital Universitario Ramón y Cajal

Madrid,

Spain

Hospital del Bierzo

Ponferrada,

Spain

Hospital Universitario Marqués de Valdecilla

Santander,

Spain

Hospital Universitario Virgen Macarena

Seville,

Spain

Hospital General Universitario de Valencia

Valencia,

Spain