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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-07790 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-0325 | Other Identifier | M D Anderson Cancer Center | |
| K23AI117024 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood, airway brushings. |
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| 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 |
| 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 |
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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:
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
Exclusion Criteria:
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Patients with BOS who have undergone an allo-HCT or lung allograft.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ajay Sheshadri | Contact | 713-792-6238 | asheshadri@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Ajay Sheshadri | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D001989 | Bronchiolitis Obliterans |
| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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Blood, airway brushings
| Medical Chart Review | Other | Patients' medical records are reviewed |
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| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |