Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Proportion of abnormal epithelial cells between patients with bronchiolitis obliterans syndrome and those without
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Bronchoscopy performed on emergency basis for life-threatening issues as opposed to routine diagnostic testing
- •Patient unwilling to give consent for study airway brushings
研究组 & 干预措施
Ancillary-correlative (biospecimen collection, chart review)
Patients undergo collection of blood samples and 6 brushings of the airway during SOC bronchoscopy. Patients' medical records are also reviewed for data collection.
干预措施: Biospecimen Collection (Procedure)
Ancillary-correlative (biospecimen collection, chart review)
Patients undergo collection of blood samples and 6 brushings of the airway during SOC bronchoscopy. Patients' medical records are also reviewed for data collection.
干预措施: Medical Chart Review (Other)
结局指标
主要结局
Proportion of abnormal epithelial cells between patients with bronchiolitis obliterans syndrome and those without
时间窗: Up 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.
次要结局
- Comparison of epithelial cell populations in allogeneic hematopoietic cell transplant recipients and lung graft recipients(Up to 1 year)