Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

Study Overview
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Brief Summary
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This study investigates a type of cell, called abnormal clonogenic epithelial cells, in patients with bronchiolitis obliterans syndrome who have had an donor stem cell transplant or a lung transplant. Learning more about clonogenic cells in these patients may help doctors to detect signs of bronchiolitis obliterans syndrome earlier in future patients.

Detailed Description
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PRIMARY OBJECTIVE: I. To characterize epithelial cell phenotypes in allogeneic hematopoietic cell transplant (allo-HCT) recipients at MD Anderson Cancer Center (MDACC) and in lung transplant recipients at Houston Methodist who have bronchiolitis obliterans syndrome (BOS). OUTLINE: Patients undergo collection of blood samples and 3 brushings of the airway during standard of care (SOC) bronchoscopy. After the bronchoscopy, patients undergo 2 nasal brushings (swabs). Patients' medical records are also reviewed for data collection. After completion of study, patients are followed for up to 1 year.

Official Title
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Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

Conditions
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Bronchiolitis Obliterans

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Medical Chart Review


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Bronchoscopy performed on emergency basis for life-threatening issues as opposed to routine diagnostic testing Patient unwilling to give consent for study airway brushings
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ancillary-correlative (biospecimen collection, chart review)<br>Patients undergo collection of blood samples and 6 brushings of the airway during SOC bronchoscopy. Patients' medical records are also reviewed for data collection. | Procedure: Biospecimen Collection<br>* Undergo collection of blood, airway brushings.<br>Other: Medical Chart Review<br>* Patients' medical records are reviewed<br>* Other names: Chart Review;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of abnormal epithelial cells between patients with bronchiolitis obliterans syndrome and those without | 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. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of epithelial cell populations in allogeneic hematopoietic cell transplant recipients and lung graft recipients | 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. | Up to 1 year |