Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchiolitis Obliterans
• Intervention / Treatment: Procedure: Biospecimen Collection; Other: Medical Chart Review

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 Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Ajay Sheshadri; Phone Number: 713-792-6238; Email: asheshadri@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Ajay Sheshadri; Phone Number: 713-792-6238
      • Principal Investigator: Ajay Sheshadri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with BOS who have undergone an allo-HCT or lung allograft.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ancillary-correlative (biospecimen collection, 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.	Procedure: Biospecimen Collection; Undergo collection of blood, airway brushings.; Other: Medical Chart Review; Patients' medical records are reviewed; Other Names: Chart Review

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of abnormal epithelial cells between patients with bronchiolitis obliterans syndrome and those without	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.	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of epithelial cell populations in allogeneic hematopoietic cell transplant recipients and lung graft recipients	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.	Up to 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Ajay Sheshadri, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2020
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchiolitis; Bronchitis; Bronchiolitis Obliterans
• Other Study ID Numbers: 2020-0325 (Other Identifier: M D Anderson Cancer Center); NCI-2020-07790 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); K23AI117024 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• product manufactured in and exported from the U.S.: No