RNA Sequencing of Discarded Tracheal Stenosis Tissue to C... | NCT07258784

Studies
RNA Sequencing of Discarded Tracheal Stenosis Tissue to Characterize Cellular and Molecular Pathogenesis

NCT07258784

Sponsor

University of Maryland, Baltimore

Status

Recruiting

Last Update Posted

Dec 2, 2025Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Tracheal Stenosis
Subglottic Stenosis

Interventions

Biopsy or surgery

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

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 11, 2025Actual

Primary Completion Date

Sep 10, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Nov 20, 2025

First Submission Date that Met QC Criteria

Nov 20, 2025

First Posted Date

Dec 2, 2025Actual

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

Nov 20, 2025

Last Update Posted Date

Dec 2, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chenchen Zhang, Assistant professor, University of Maryland, BaltimorePrincipal Investigator

Lead Sponsor

University of Maryland, BaltimoreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Benign tracheal stenosis is a rare but potentially life-threatening condition, typically resulting from fibroinflammatory scarring. It can be secondary to iatrogenic etiologies such as intubation or tracheostomy , as well as autoimmune diseases and being idiopathic. Patients typically undergoes endoscopic or surgical interventions to open up the airways. This project will analyze resected or biopsied tissue from patients with benign tracheal stenosis to define disease-specific RNA expression profiles.

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

Retention

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with benign tracheal stenosis undergoing either endoscopic or surgical treatment			Procedure: Biopsy or surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biopsy or surgery	Procedure	The tissue will be obtained from biopsy or surgical resection. All the "intervention" will be performed for clinical needs. The tissue used in the study will be considered as discarded tissue

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
RNA profile	The diseased mucosa will show a increased fibrosis and inflammation profile compared with that from normal mucosa	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with benign tracheal stenosis

Exclusion Criteria:

Malignancy. active infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients with benign tracheal stenosis, including idiopathic, iatrogenic, autoimmune.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chenchen Zhang, MD	Contact	14103288141		chenchen.zhang@som.umaryland.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Maryland	Recruiting	Baltimore	Maryland	21201	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014135	Tracheal Stenosis

Ancestor Terms

ID	Term
D014133	Tracheal Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001706	Biopsy
D013514	Surgical Procedures, Operative

Ancestor Terms

ID	Term
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided