Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04604522
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Enrollment: 15
• Location: 1
• Anticipated Duration (Months): 43.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis Obliterans	Procedure: Biospecimen Collection; Other: Medical Chart Review

Detailed Description

PRIMARY OBJECTIVE:

1. 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 Design

• Study Type: Observational
• Anticipated Enrollment: 15 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome
• Actual Study Start Date: Aug 27, 2020
• Anticipated Primary Completion Date: Mar 31, 2024
• Anticipated Study Completion Date: Mar 31, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Ajay Sheshadri, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• MD Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT04604522
• Other Study ID Numbers: 2020-0325; NCI-2020-07790; 2020-0325; K23AI117024
• First Posted: Oct 27, 2020
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Additional relevant MeSH terms: Bronchiolitis; Bronchiolitis Obliterans

Study Results

No Results Posted as of Jul 19, 2022