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Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

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Overview

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.

Description

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.

Eligibility

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

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

Study details
    Bronchiolitis Obliterans

NCT04604522

M.D. Anderson Cancer Center

28 January 2024

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