Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

Bronchiolitis Obliterans Clinical Trial

Official title:

Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04604522
• Other study ID #: 2020-0325
• Secondary ID: NCI-2020-0779020
• Status: Recruiting
• Start date: August 27, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: Ajay Sheshadri
• Phone: 713-792-6238
• Email: asheshadri[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Obliterans
• Bronchiolitis Obliterans Syndrome

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood, airway brushings.

Other:
• Medical Chart Review
Patients' medical records are reviewed

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   MD Anderson Cancer Center