Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Bronchiolitis Obliterans

Treatments: Other: Medical Chart Review; Procedure: Biospecimen Collection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04604522

2020-0325 (Other Identifier)

NCI-2020-07790 (Registry Identifier)

K23AI117024 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 1 patient group

Ancillary-correlative (biospecimen collection, chart review)

Description:

Patients undergo collection of blood samples and 6 brushings of the airway during SOC bronchoscopy. Patients' medical records are also reviewed for data collection.

Treatment:

Procedure: Biospecimen Collection

Other: Medical Chart Review