NCT07258784

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Sep 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Sep 2025Dec 2026

Study Start

First participant enrolled

September 11, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

December 2, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

November 20, 2025

Last Update Submit

November 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • RNA profile

    The diseased mucosa will show a increased fibrosis and inflammation profile compared with that from normal mucosa

    1 year

Study Arms (1)

patients with benign tracheal stenosis undergoing either endoscopic or surgical treatment

Procedure: Biopsy or surgery

Interventions

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

patients with benign tracheal stenosis undergoing either endoscopic or surgical treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients with benign tracheal stenosis

You may not qualify if:

  • Malignancy. active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biopsied or resected stenotic tissue from patients with benign tracheal stenosis

MeSH Terms

Conditions

Tracheal Stenosis

Interventions

BiopsySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Tracheal DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalInvestigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 2, 2025

Study Start

September 11, 2025

Primary Completion (Estimated)

September 10, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 2, 2025

Record last verified: 2025-09

Locations