NCT06272123

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

2.1 years

First QC Date

January 23, 2024

Last Update Submit

February 20, 2024

Conditions

Chronic Sinusitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • SF-36

    1 year

  • SNOT-22

    1 year

Study Arms (2)

Chronic Sinusitis

Other: no intervention

Controls

Other: no intervention

Interventions

no interventionOTHER

no intervention

Chronic SinusitisControls

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Department of Otolaryngology

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Study Design

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

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 22, 2024

Study Start

January 1, 2024

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations

US(1)