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Recruiting NCT04604522

Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

— Observational Bronchiolitis Obliterans

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biospecimen Collection, Medical Chart Review.
Who it may be relevant to
Registry conditions: Bronchiolitis Obliterans. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

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.

Interventions

  • Procedure Biospecimen Collection
    Undergo collection of blood, airway brushings.
  • Other Medical Chart Review
    Patients' medical records are reviewed

Primary outcome measures

  • Proportion of abnormal epithelial cells between patients with bronchiolitis obliterans syndrome and those without [Time frame: Up to 1 year]
Secondary outcome measures (1)
  • Comparison of epithelial cell populations in allogeneic hematopoietic cell transplant recipients and lung graft recipients [Time frame: 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT04604522 · 2020-0325 · NCI-2020-07790 · 2020-0325 · K23AI117024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗