Clinical trial NCT04604522: Evaluating Clonogenic Epithelial Cell Populations in Patients with Bronchiolitis Obliterans Syndrome
Official title: Evaluating Clonogenic Epithelial Cell Populations in Patients with Bronchiolitis Obliterans Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchiolitis Obliterans
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2020-10-27
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with BOS who have undergone an allo-HCT or lung allograft.

Brief summary: 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.

Detailed 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 criteria: 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

Primary outcomes:
measure: Proportion of abnormal epithelial cells between patients with bronchiolitis obliterans syndrome and those without
timeFrame: Up to 1 year
Secondary outcomes:
measure: Comparison of epithelial cell populations in allogeneic hematopoietic cell transplant recipients and lung graft recipients
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ajay Sheshadri
role: PRINCIPAL_INVESTIGATOR
References: