RecruitingNCT04604522
Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome
Sponsor
M.D. Anderson Cancer Center
Enrollment
15 participants
Start Date
Aug 27, 2020
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria11
- 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)
- 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)
- 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
- 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
- patients with BOS Stage 2 or higher (\>= 35% decline in FEV1 from baseline values)
- patient with BOS Stage 0p or 1 (10-35% decline in FEV1 from baseline values)
- 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 Criteria2
- Bronchoscopy performed on emergency basis for life-threatening issues as opposed to routine diagnostic testing
- Patient unwilling to give consent for study airway brushings
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Interventions
PROCEDUREBiospecimen Collection
Undergo collection of blood, airway brushings.
OTHERMedical Chart Review
Patients' medical records are reviewed
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04604522