Evaluating Clonogenic Epithelial Cells in Bronchiolitis Obliterans Syndrome

This study is looking at special cells called abnormal clonogenic epithelial cells in people who have bronchiolitis obliterans syndrome (BOS). BOS is a serious lung disease that can happen after a stem cell transplant or lung transplant. Researchers will collect blood and airway brushings (a way to collect cells from your airways) during a standard bronchoscopy, and also review your medical records. By studying these cells, doctors hope to learn more about BOS and find ways to detect it earlier in future patients. The study aims to compare these cells in people with and without BOS. They are looking for about 15 participants.

Study design
This is an observational study, meaning researchers will collect information without giving any new treatments. It plans to include 15 participants.
What's involved
You would undergo collection of blood samples and airway brushings during a standard bronchoscopy, and also have two nasal brushings. Your medical records will also be reviewed.
Compensation
Not stated in the trial record.
Follow-up
After the study procedures, participants will be followed for up to one year.

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NCT04604522

Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

Recruiting
Not specifiedAll AgesObservational
M.D. Anderson Cancer Center
~15 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:Biospecimen CollectionMedical Chart Review

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of abnormal epithelial cells between patients with bronchiolitis obliterans syndrome and those without
Measured over Up to 1 year
Bronchiolitis Obliterans
1 sites across 1 states
Texas1
  • Ajay Sheshadri · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Allo-HCT recipients undergoing a bronchoscopy at MDACC who consent to undergoing study airway brushings in addition to clinically indicated bronchoscopic procedures (e.g. bronchoalveolar lavage)
5 patients with advanced BOS - forced expiratory volume in one second (FEV1) =\< 75% predicted and meeting other National Institutes of Health (NIH) criteria (FEV1/forced vital capacity \[FVC\] ratio 0.7, presence of air trapping or graft versus host disease \[GVHD\] of another organ)
5 patient with early BOS - at least 10% decline in FEV1 from baseline values, with FEV1 \>= 75% predicted, and 1 high-risk feature:
Active systemic chronic GVHD with new early airflow obstruction OR
Respiratory viral infection in last three months with resolution of viral symptoms but new airflow obstruction
3 patients with no pulmonary impairment (FEV1 within 5% of baseline values)
Lung allograft recipients undergoing a bronchoscopy at Houston Methodist who consent to undergoing study airway brushing sin addition to clinically indicated bronchoscopy procedures
5 patients with BOS Stage 2 or higher (\>= 35% decline in FEV1 from baseline values)
5 patient with BOS Stage 0p or 1 (10-35% decline in FEV1 from baseline values)
3 patients undergoing screening bronchoscopy without decline in FEV1
patients with undiagnosed lung cancer and chronic obstructive pulmonary disease diagnosed by pulmonary function testing (FEV1/FVC less than the lower limit of normal with \>20 pack-year history of smoking)

Exclusion

Bronchoscopy performed on emergency basis for life-threatening issues as opposed to routine diagnostic testing
Patient unwilling to give consent for study airway brushings
  • Proportion of abnormal epithelial cells between patients with bronchiolitis obliterans syndrome and those withoutUp to 1 year

    The relationship between the proportion of abnormal cells and degree of air trapping and lung abnormalities will be described through simple correlation. Exploration of non-linear relationships or rank-based summaries will be considered as appropriate.