CRS Questionnaire Validation Project

NCT ID: NCT06970977

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-09-30

Brief Summary

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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

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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.

Conditions

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Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCLA Santa Monica Medical Center

Santa Monica, California, United States

Site Status RECRUITING

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Site Status RECRUITING

Brigham Sinus Center at Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Eastern Virginia Medical School

Virginia City, Virginia, United States

Site Status RECRUITING

UZ Gent

Ghent, , Belgium

Site Status NOT_YET_RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

St. Michael's Hospital

Toronto, , Canada

Site Status RECRUITING

Univ of Copenhagen

Copenhagen, , Denmark

Site Status RECRUITING

HNO-Klinik, Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Site Status NOT_YET_RECRUITING

Univ Munich

Munich, , Germany

Site Status NOT_YET_RECRUITING

University General Hospital of Heraklion

Heraklion, , Greece

Site Status RECRUITING

U. Aristotle

Thessaloniki, , Greece

Site Status RECRUITING

Univ Hospital Roma

Roma, , Italy

Site Status RECRUITING

Univ Amsterdam

Amsterdam, , Netherlands

Site Status NOT_YET_RECRUITING

Alrijne Zorggroep

Leiden, , Netherlands

Site Status RECRUITING

University of Oradea

Oradea, , Romania

Site Status RECRUITING

Ahmed Alkhadi Hospital

Durban, , South Africa

Site Status RECRUITING

Hospital Clínico Universitario de Compostela

A Coruña, , Spain

Site Status RECRUITING

Hospital Clinic Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Hospital de La Línea de La Concepción

Cadiz, , Spain

Site Status RECRUITING

Hospital Universitario Jerez de La Frontera

Cadiz, , Spain

Site Status RECRUITING

Hospital Universitario Puerta del Mar

Cadiz, , Spain

Site Status RECRUITING

Hospital Universitario Puerto Real

Cadiz, , Spain

Site Status RECRUITING

Hospital Universitario Fuenlabrada

Madrid, , Spain

Site Status RECRUITING

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

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status RECRUITING

Hospital del Bierzo

Ponferrada, , Spain

Site Status RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Site Status RECRUITING

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status RECRUITING

Hospital General Universitario de Valencia

Valencia, , Spain

Site Status RECRUITING

Countries

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United States Belgium Canada Denmark Germany Greece Italy Netherlands Romania South Africa Spain

Facility Contacts

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Jivianne Lee

Role: primary

+1 310-825-9111

Anju Peters

Role: primary

+1 312-503-8194

Stella Lee

Role: primary

+1(617) 525-6500

Elina Toskala

Role: primary

+1 215-955-6000

Joseph Han

Role: primary

+1 757-446-5600

Philippe Gevaert

Role: primary

Peter Hellings

Role: primary

+32 16 33 23 40

Diego Conti

Role: backup

Yvonne Chan

Role: primary

Vibeke Backer

Role: primary

Martin Wagenmann

Role: primary

Adam Chaker

Role: primary

Emmanuel Prokopakis

Role: primary

Ioannis Konstantinidis

Role: primary

Eugenio De Corso

Role: primary

Wytske Fokkens

Role: primary

Marjolein Cornet

Role: primary

Felicia Manole

Role: primary

Devesh Ramdhani

Role: primary

Christian Calvo Henriquez

Role: primary

Isam Alobid

Role: primary

Juan Ramon Gras Cabrerizo

Role: primary

Eduardo Correa

Role: primary

Alfonso Del Cuvillo Bernal

Role: primary

Andrés Caballero García

Role: primary

Carlos Almagro Ordoñez

Role: primary

Ithzel María Villareal

Role: primary

Alvaro Sanchez Barrueco

Role: primary

Alfonso Santamaría Gadea

Role: primary

Xenia Mota

Role: primary

David Lobo Duro

Role: primary

Ramón Moreno Luna

Role: primary

Ainhoa García Lliberós de Miguel

Role: primary

Other Identifiers

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S68027

Identifier Type: -

Identifier Source: org_study_id

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