Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

Recruiting

• Conditions: Bronchiolitis Obliterans
• Interventions: Procedure: Biospecimen Collection; Other: Medical Chart Review

• Registration Number: NCT04604522
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2020-08-27
• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-correlative (biospecimen collection, chart review)	Biospecimen Collection	Patients undergo collection of blood samples and 6 brushings of the airway during SOC bronchoscopy. Patients' medical records are also reviewed for data collection.
Ancillary-correlative (biospecimen collection, chart review)	Medical 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.

Primary Outcome Measures

Name	Time	Method
Proportion of abnormal epithelial cells between patients with bronchiolitis obliterans syndrome and those without	Up to 1 year	The relationship between the proportion of abnormal cells and degree of air trapping and lung abnormalities will be described through simple correlation. Exploration of non-linear relationships or rank-based summaries will be considered as appropriate.

Secondary Outcome Measures

Name	Time	Method
Comparison of epithelial cell populations in allogeneic hematopoietic cell transplant recipients and lung graft recipients	Up to 1 year	The relationship between the proportion of abnormal cells and degree of air trapping and lung abnormalities will be described through simple correlation. Exploration of non-linear relationships or rank-based summaries will be considered as appropriate.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States