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Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04604522
Enrollment
15
Registered
2020-10-27
Start date
2020-08-27
Completion date
2026-03-31
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis Obliterans

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.

Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood, airway brushings.

OTHERMedical Chart Review

Patients' medical records are reviewed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of abnormal epithelial cells between patients with bronchiolitis obliterans syndrome and those withoutUp to 1 yearThe 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

MeasureTime frameDescription
Comparison of epithelial cell populations in allogeneic hematopoietic cell transplant recipients and lung graft recipientsUp to 1 yearThe 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.

Countries

United States

Contacts

CONTACTAjay Sheshadri
asheshadri@mdanderson.org713-792-6238
PRINCIPAL_INVESTIGATORAjay Sheshadri

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026