Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-27

Study Completion Date

2026-03-31

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.

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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.

Conditions

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Bronchiolitis Obliterans

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood, airway brushings.

Medical Chart Review

Intervention Type OTHER

Patients' medical records are reviewed

Interventions

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Biospecimen Collection

Undergo collection of blood, airway brushings.

Intervention Type PROCEDURE

Medical Chart Review

Patients' medical records are reviewed

Intervention Type OTHER

Other Intervention Names

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Chart Review

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
* 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 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No