The Longitudinal Impact of Respiratory Viruses on Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Cell Transplantation (The RV-BOS Study)
Summary
This observational trial studies whether respiratory viruses are the cause of lung disease (bronchiolitis obliterans syndrome \[BOS\] or graft-versus-host disease of the lung) and changes in lung function in patients who have received a donor stem cell transplant. Patients with chronic graft-versus-host disease (cGVHD) are at higher risk of developing BOS. Studies have also shown that patients who had a respiratory viral illness early after their transplant are at higher risk of developing lung problems later on. Patients who are at risk and who already have BOS might benefit from being monitored more closely. Spirometry is a way of assessing a patient's lung function and is often used to diagnose lung disease. Spirometry measured at home with a simple handheld device may reduce the burden of performing pulmonary function testing at a facility and potentially help patients get their lung disease diagnosed and treated sooner.
Detailed description
OUTLINE: This is an observational study. Patients undergo home spirometry measurements with a portable handheld spirometer and complete questionnaires weekly, a nasal swab for viral polymerase chain reaction (PCR) surveillance every 4 weeks, and undergo blood collection and nasal swabs every 3 months for up to 2 years. (The minimum required follow-up is 1 year, but there is an optional 1 year extension period.)
Arms & interventions
- ProcedureHome spirometry
Undergo spirometry measurements
- ProcedureBiospecimen Collection
Undergo nasal and/or oral swabs, and blood collection
- OtherQuestionnaire Administration
Complete questionnaires
Outcome measures
Primary
Incidence of bronchiolitis obliterans syndrome (BOS)
Diagnosed by National Institute of Health criteria or clinical diagnosis in the absence of alternative diagnosis.
Time frame: Up to 2 years
Pulmonary impairment
Defined by temporal decline in forced expiratory volume in the first second (FEV1) determined by assessment of spirometry data.
Time frame: Up to 2 years
Secondary
Time from respiratory viral infection and chronic graft-versus-host disease to FEV1 decline
Time frame: Up to 2 years
FEV1 (percent predicted) at clinical recognition of BOS
Time frame: Up to 2 years
Incidence of asymptomatic and symptomatic viral infections
Time frame: Up to 2 years
Incidence of late onset noninfectious pulmonary complications
Time frame: Up to 2 years
Incidence of non-viral infectious pulmonary complications
Time frame: Up to 2 years
Establishment of a biorepository that includes blood samples, respiratory viral samples, and nasal microbiome samples from patients with clinically recognized BOS
Time frame: Up to 2 years
Eligibility criteria
Study locations (4)
Stanford Cancer Institute
Palo Alto, California, 94304
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
MD Anderson Cancer Center
Houston, Texas, 77030
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109