Endotypic Stability in CRS

Recruiting

• Conditions: Chronic Sinusitis

• Registration Number: NCT06272123
• Lead Sponsor: Thomas Jefferson University

Brief Summary

A Case control study with 150 cases and 50 controls will be conducted. Immunologic (cytokines measurements in nasal secretions and sinonasal tissues), histopathologic (tissue eosinophilia) and clinical parameters (Lund-Mackay and Lund-Kennedy score, lung function tests), surveys (SNOT- 22, SF-36 quality of life survey) will be compared between different groups of patients

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-01-23
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-20
• Last Update Submitted: 2024-02-20
• Study First Posted: 2024-02-22
• Last Update Posted: 2024-02-22
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients with Chronic sinusitis (with or without polyps)
• Undergoing endoscopic sinus surgery during the study period
• More than 18 years
• No chronic illness/ malignancy

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endotypic markers	1 year	The primary outcome measure assessed through this study is the presence of endotypic markers including: IL-5, IFN-gamma, IL-17a, TNF-alpha, and IL-22 in tissue biopsy samples across multiple racial/ethnic groups.

Secondary Outcome Measures

Name	Time	Method
SF-36	1 year	Differences in SF-36 scores between ethnic groups.
SNOT-22	1 year	Differences in SNOT-22 scores between ethnic groups.

Trial Locations

Locations (1)

Thomas Jefferson University Department of Otolaryngology; 🇺🇸 Philadelphia, Pennsylvania, United States