Clinical trial NCT06970977: CRS Questionnaire Validation Project
Official title: CRS Questionnaire Validation Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Lead sponsor: The European Forum for Research and Education in Allergy and Airway Diseases
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients, capable of giving consent, with certified CRS and no recent sinus surgery

Brief 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: 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)

Primary outcomes:
measure: Validation of a new questionnaire
timeFrame: Through study completion, an average of 6 months
measure: Evaluation of the results
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Validation of a new questionnaire
timeFrame: Through study completion, an average of 6 months
measure: Evaluation of the results
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: UCLA Santa Monica Medical Center
state: California
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Boston
country: United States
facility: Brigham Sinus Center at Brigham and Women's Hospital
state: Massachusetts
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Virginia
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Toronto
country: Canada
facility: St. Michael's Hospital
city: Copenhagen
country: Denmark
facility: Univ of Copenhagen
city: Düsseldorf
country: Germany
facility: HNO-Klinik, Universitätsklinikum Düsseldorf
city: Munich
country: Germany
facility: Univ Munich
city: Iraklio
country: Greece
facility: University General Hospital of Heraklion
city: Thessaloniki
country: Greece
facility: U. Aristotle
city: Roma
country: Italy
facility: Univ Hospital Roma
city: Amsterdam
country: Netherlands
facility: Univ Amsterdam
city: Leiden
country: Netherlands
facility: Alrijne Zorggroep
city: Oradea
country: Romania
facility: University of Oradea
city: Durban
country: South Africa
facility: Ahmed Alkhadi Hospital
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Cadiz
country: Spain
facility: Hospital Universitario Jerez de La Frontera
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Cadiz
country: Spain
facility: Hospital Universitario Puerto Real
city: Cádiz
country: Spain
facility: Hospital de La Línea de La Concepción
city: La Coruña
country: Spain
facility: Hospital Clínico Universitario de Compostela
city: Madrid
country: Spain
facility: Hospital Universitario Fuenlabrada
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Elena, Madrid y Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Ponferrada
country: Spain
facility: Hospital del Bierzo
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
Study officials:
References: