About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
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
Disqualifiers
Bronchoscopy performed on emergency basis for life-threatening issues as opposed to routine diagnostic testing
Patient unwilling to give consent for study airway brushings
Trial population
Patients with BOS who have undergone an allo-HCT or lung allograft.
Trial design
Cohort
Prospective
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood, airway brushings.
Medical Chart Review
Other interventionPatients' medical records are reviewed
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Sponsors and contacts
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M.D. Anderson Cancer Center
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator