Chronic Sinusitis Clinical Trial
Official title:
Comparison of Endotypic Stability in Various Populations With Chronic Sinusitis
| NCT number | NCT06272123 |
| Other study ID # | 20D.776 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 1, 2024 |
| Est. completion date | January 31, 2026 |
| Verified date | February 2024 |
| Source | Thomas Jefferson University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | January 31, 2026 |
| Est. primary completion date | January 31, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Thomas Jefferson University Department of Otolaryngology | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Thomas Jefferson University | GlaxoSmithKline |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Endotypic markers | 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. | 1 year | |
| Secondary | SF-36 | Differences in SF-36 scores between ethnic groups. | 1 year | |
| Secondary | SNOT-22 | Differences in SNOT-22 scores between ethnic groups. | 1 year |
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