Actively Recruiting
Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome
Led by M.D. Anderson Cancer Center · Updated on 2026-03-11
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to study abnormal clonogenic epithelial cells in patients with bronchiolitis obliterans syndrome (BOS) who have undergone either an allogeneic hematopoietic cell transplant or a lung transplant. By examining these cells, researchers hope to better understand BOS and improve early detection in future patients. The study involves participants from MD Anderson Cancer Center and Houston Methodist who have BOS and have undergone transplants. Participants will provide blood samples and undergo multiple airway brushings during their standard of care bronchoscopy procedure. After the bronchoscopy, they will have nasal brushings collected as well. Researchers will also review the participants' medical records to gather additional data. This study does not involve any investigational drugs or treatment changes but focuses on biospecimen collection and chart review. During the study, participants will be monitored and followed for up to one year after their initial procedures. Researchers will measure the proportion of abnormal epithelial cells and compare epithelial cell populations among different transplant recipient groups. The study includes various assessments such as bronchoscopy, blood sample collection, nasal brushings, and medical record review to understand the cellular changes associated with BOS.
CONDITIONS
Brief Title
Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recipients of allogeneic hematopoietic cell transplant undergoing bronchoscopy at MD Anderson Cancer Center who consent to additional airway brushings
- Patients with advanced bronchiolitis obliterans syndrome (FEV1 ≤ 75% predicted and meeting NIH criteria)
- Patients with early bronchiolitis obliterans syndrome showing at least 10% decline in FEV1 with a high-risk feature
- Patients with no pulmonary impairment (FEV1 within 5% of baseline)
- Lung transplant recipients undergoing bronchoscopy at Houston Methodist who consent to additional airway brushings
- Patients with bronchiolitis obliterans syndrome Stage 2 or higher (≥ 35% decline in FEV1)
- Patients with bronchiolitis obliterans syndrome Stage 0p or 1 (10-35% decline in FEV1)
- Patients undergoing screening bronchoscopy without FEV1 decline
- Patients with undiagnosed lung cancer or chronic obstructive pulmonary disease diagnosed by pulmonary function testing
You will not qualify if you...
- Bronchoscopy performed as an emergency for life-threatening issues instead of routine diagnostic testing
- Patients unwilling to give consent for study airway brushings
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants undergo standard of care bronchoscopy with additional airway brushings and blood sample collections for research purposes. Medical records are also reviewed for data collection.
1 visit (in-person during bronchoscopy)
Duration - Up to 1 year
After completing the study procedures, participants are followed for up to 1 year to monitor outcomes related to bronchiolitis obliterans syndrome.
Follow-up visits as per routine clinical care
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Ajay Sheshadri
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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