Endotypic Stability in CRS | NCT06272123

Studies
Endotypic Stability in CRS

NCT06272123

Sponsor

Thomas Jefferson University

Status

Unknown status

Last Update Posted

Feb 22, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Chronic Sinusitis

Interventions

no intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

Jan 31, 2026Estimated

Completion Date

Jan 31, 2026Estimated

First Submitted Date

Jan 23, 2024

First Submission Date that Met QC Criteria

Feb 20, 2024

First Posted Date

Feb 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2024

Last Update Posted Date

Feb 22, 2024Actual

Name	Class
GlaxoSmithKline	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chronic Sinusitis			Other: no intervention
Controls			Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention	Chronic Sinusitis Controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thomas Jefferson University Department of Otolaryngology	Recruiting	Philadelphia	Pennsylvania	19107	United States