Endotypic Stability in CRS

February 20, 2024 updated by: Thomas Jefferson University

Comparison of Endotypic Stability in Various Populations With Chronic Sinusitis

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Department of Otolaryngology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Chronic sinusitis (with or without polyps) undergoing endoscopic sinus surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Controls
Other: no intervention
no intervention
Chronic Sinusitis
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endotypic markers
Time Frame: 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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SF-36
Time Frame: 1 year
Differences in SF-36 scores between ethnic groups.
1 year
SNOT-22
Time Frame: 1 year
Differences in SNOT-22 scores between ethnic groups.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Collaborators

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

February 20, 2024

First Posted (Estimated)

February 22, 2024

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20D.776

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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