Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

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

Disqualifiers

Bronchoscopy performed on emergency basis for life-threatening issues as opposed to routine diagnostic testing

Patient unwilling to give consent for study airway brushings

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood, airway brushings.

  • Medical Chart Review

    Other intervention

    Patients' medical records are reviewed

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Ancillary-correlative (biospecimen collection, chart review)2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 1 year

Secondary outcomes

1

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.

Time frame
Up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator