CRS Questionnaire Validation Project

NCT06970977 | Recruiting DMC

• 1 other identifier: S68027
• Study Type: observational
• Target: 1,000
• Locations: 11 countries
• Sites: 32

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.

Conditions

Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Outcome Measures

Primary Outcomes (2)

• Validation of a new questionnaire

  Validation of a questionnaire based on similar questionnaires already approved for use in other airway diseases. The aim to measure the current perceived status of a patient with chronic rhinosinusitis in terms of control and severity. A new questionnaire will be tested and compared with current tools. For this purpose, a set of questionnaires has been developed including the EPOS criteria for chronic rhinosinusitis, the SNOT-22, the patient global assessment tool and the VAS scores, among others. All these questionnaires will be completed by the patient at visit 1 and the results will be analysed once the recruitment target of 1,000 patients has been reached. No second patient participation is required.

  Through study completion, an average of 6 months

• Evaluation of the results

  Evaluation of the results of this questionnaire in comparison with other tools currently available. Once the target of recruiting 1000 patients has been reached, the results will be statistically analysed. Parallels will be drawn between the responses obtained by the usual means and those captured in the questionnaires to be validated. It is expected that, in all cases, the degree of control and severity represented in the questionnaires to be validated will conform to the EPOS criteria and to the results of the questionnaires usually used. The results will be compared for each of the new questionnaires in general and separately by language. The ultimate goal is to validate what will become the diagnostic gold standard for chronic rhinosinusitis.

  Through study completion, an average of 6 months

Secondary Outcomes (2)

• Validation of a new questionnaire

  Through study completion, an average of 6 months

• Evaluation of the results

  Through study completion, an average of 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients, capable of giving consent, with certified CRS and no recent sinus surgery

You may qualify if:

• 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)

You may not qualify if:

• Not capable of giving informed consent
• No CRS
• Recent sinus surgery (within the last three months)

Sponsors & Collaborators

• The European Forum for Research and Education in Allergy and Airway Diseases: lead

Study Sites (32)

UCLA Santa Monica Medical Center

Santa Monica, California, 90401, United States

RECRUITING

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60208, United States

RECRUITING

Brigham Sinus Center at Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Eastern Virginia Medical School

Virginia City, Virginia, 23507, United States

RECRUITING

UZ Gent

Ghent, Belgium

NOT YET RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

St. Michael's Hospital

Toronto, Canada

RECRUITING

Univ of Copenhagen

Copenhagen, Denmark

RECRUITING

HNO-Klinik, Universitätsklinikum Düsseldorf

Düsseldorf, Germany

NOT YET RECRUITING

Univ Munich

Munich, Germany

NOT YET RECRUITING

University General Hospital of Heraklion

Heraklion, Greece

RECRUITING

U. Aristotle

Thessaloniki, Greece

RECRUITING

Univ Hospital Roma

Roma, Italy

RECRUITING

Univ Amsterdam

Amsterdam, Netherlands

NOT YET RECRUITING

Alrijne Zorggroep

Leiden, Netherlands

RECRUITING

University of Oradea

Oradea, Romania

RECRUITING

Ahmed Alkhadi Hospital

Durban, South Africa

RECRUITING

Hospital Clínico Universitario de Compostela

A Coruña, Spain

RECRUITING

Hospital Clinic Barcelona

Barcelona, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

Hospital de La Línea de La Concepción

Cadiz, Spain

RECRUITING

Hospital Universitario Jerez de La Frontera

Cadiz, Spain

RECRUITING

Hospital Universitario Puerta del Mar

Cadiz, Spain

RECRUITING

Hospital Universitario Puerto Real

Cadiz, Spain

RECRUITING

Hospital Universitario Fuenlabrada

Madrid, Spain

RECRUITING

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

Madrid, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Spain

RECRUITING

Hospital del Bierzo

Ponferrada, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, Spain

RECRUITING

Hospital General Universitario de Valencia

Valencia, Spain

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 14, 2025
• Study Start: September 1, 2024
• Primary Completion: June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

ZA (1); ES (14); CA (1); IT (1); DE (2); DK (1); GR (2); NL (2); US (5); BE (2); RO (1)