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

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.

Study Overview

• Status: Recruiting
• Conditions: Tracheal Stenosis; Subglottic Stenosis
• Intervention / Treatment: Procedure: Biopsy or surgery

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Chenchen Zhang, MD; Phone Number: 14103288141; Email: chenchen.zhang@som.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland
      • Contact: Chenchen Zhang; Phone Number: 4103288141; Email: chenchen.zhang@som.umaryland.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Patients with benign tracheal stenosis

Exclusion Criteria:

• Malignancy. active infection

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with benign tracheal stenosis undergoing either endoscopic or surgical treatment	Procedure: Biopsy or surgery; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2025
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Tracheal Diseases; Tracheal Stenosis; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytological Techniques; Cytodiagnosis; Diagnostic Techniques, Surgical; Biopsy; Surgical Procedures, Operative
• Other Study ID Numbers: HP-00114191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No