Tracheal StenosisNCT07258784
RNA Sequencing of Discarded Tracheal Stenosis Tissue to Characterize Cellular and Molecular Pathogenesis
An observational study of Tracheal Stenosis and Subglottic Stenosis, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tracheal Stenosis, Subglottic Stenosis
- What is being tested?
- Biopsy or surgery
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with benign tracheal stenosis, including idiopathic, iatrogenic, autoimmune.
Who may be able to join
- Patients with benign tracheal stenosis
Who cannot join
- Malignancy. active infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
Chenchen Zhang, 4103288141, chenchen.zhang@som.umaryland.edu
About this study
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.
- Conditions
- Tracheal Stenosis, Subglottic Stenosis
- Being tested
- Biopsy or surgery
- Medical subject headings
- Tracheal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy or surgeryProcedure 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
| Study group | Role | What they receive |
|---|---|---|
| patients with benign tracheal stenosis undergoing either endoscopic or surgical treatment | Not described Receives: Procedure: Biopsy or surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
RNA profile
The diseased mucosa will show a increased fibrosis and inflammation profile compared with that from normal mucosa
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start11 Sep 2025
- Primary completion10 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal StenosisStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chenchen Zhang, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258784
- Sponsor's protocol ID
- HP-00114191
- Status last verified
- Sep 2025
- First submitted
- 20 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RNA Sequencing of Discarded Tracheal Stenosis Tissue to Characterize Cellular and Molecular Pathogenesis
- ClinicalTrials.gov ID
- NCT07258784
- Acronym / sponsor ID
- HP-00114191
- Conditions
- Tracheal Stenosis, Subglottic Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with benign tracheal stenosis undergoing either endoscopic or surgical treatment | – | Procedure: Biopsy or surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with benign tracheal stenosis, including idiopathic, iatrogenic, autoimmune.
Key inclusion criteria (1 listed)
- Patients with benign tracheal stenosis
Key exclusion criteria (1 listed)
- Malignancy. active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy or surgeryThe 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 | Procedure or surgery | patients with benign tracheal stenosis undergoing either endoscopic or surgical treatment |
Primary outcome
RNA profile
Time frame: 1 year
The diseased mucosa will show a increased fibrosis and inflammation profile compared with that from normal mucosa
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheal Stenosis and Subglottic Stenosis, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chenchen Zhang, MD (14103288141, chenchen.zhang@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RNA profile (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.