CRS Questionnaire Validation Project

Last updated: May 6, 2025
Sponsor: The European Forum for Research and Education in Allergy and Airway Diseases
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polyps

Soft Tissue Infections

Sinusitis

Treatment

N/A

Clinical Study ID

NCT06970977
S68027
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient capable of giving informed consent

  • Diagnosis of chronic rhinosinusitis with or without nasal polyposis according to theEPOS guidelines

  • No recent sinus surgery (within the last three months)

Exclusion

Exclusion Criteria:

  • Not capable of giving informed consent

  • No CRS

  • Recent sinus surgery (within the last three months)

Study Design

Total Participants: 1000
Study Start date:
September 01, 2024
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • UZ Gent

    Gent,
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven,
    Belgium

    Active - Recruiting

  • St. Michael's Hospital

    Toronto,
    Canada

    Active - Recruiting

  • Univ of Copenhagen

    Copenhagen,
    Denmark

    Active - Recruiting

  • HNO-Klinik, Universitätsklinikum Düsseldorf

    Düsseldorf,
    Germany

    Site Not Available

  • Univ Munich

    Munich,
    Germany

    Site Not Available

  • University General Hospital of Heraklion

    Iraklio,
    Greece

    Active - Recruiting

  • U. Aristotle

    Thessaloniki,
    Greece

    Active - Recruiting

  • Univ Hospital Roma

    Roma,
    Italy

    Active - Recruiting

  • Univ Amsterdam

    Amsterdam,
    Netherlands

    Site Not Available

  • Alrijne Zorggroep

    Leiden,
    Netherlands

    Active - Recruiting

  • University of Oradea

    Oradea,
    Romania

    Active - Recruiting

  • Ahmed Alkhadi Hospital

    Durban,
    South Africa

    Active - Recruiting

  • Hospital Clinic Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario Jerez de La Frontera

    Cadiz,
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta del Mar

    Cadiz,
    Spain

    Active - Recruiting

  • Hospital Universitario Puerto Real

    Cadiz,
    Spain

    Active - Recruiting

  • Hospital de La Línea de La Concepción

    Cádiz,
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Compostela

    La Coruña,
    Spain

    Active - Recruiting

  • Hospital Universitario Fuenlabrada

    Madrid,
    Spain

    Active - Recruiting

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

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid,
    Spain

    Active - Recruiting

  • Hospital del Bierzo

    Ponferrada,
    Spain

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Sevilla,
    Spain

    Active - Recruiting

  • Hospital General Universitario de Valencia

    Valencia,
    Spain

    Active - Recruiting

  • UCLA Santa Monica Medical Center

    Santa Monica, California 90401
    United States

    Active - Recruiting

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois 60208
    United States

    Active - Recruiting

  • Brigham Sinus Center at Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Eastern Virginia Medical School

    Virginia, Virginia 23507
    United States

    Active - Recruiting

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