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.
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.)
Study Type
OBSERVATIONAL
Enrollment
250
Undergo spirometry measurements
Undergo nasal and/or oral swabs, and blood collection
Complete questionnaires
Stanford Cancer Institute
Palo Alto, California, United States
RECRUITINGUniversity of Michigan Cancer Center
Ann Arbor, Michigan, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGFred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
RECRUITINGIncidence 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
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
Will be determined by the longitudinal follow-up of this observational study.
Time frame: Up to 2 years
Incidence of late onset noninfectious pulmonary complications
Will be determined by the longitudinal follow-up of this observational study. Follow-up of clinical encounters will provide an epidemiology of the incidence of noninfectious and infectious pulmonary complications.
Time frame: Up to 2 years
Incidence of non-viral infectious pulmonary complications
Will be determined by the longitudinal follow-up of this observational study. Follow-up of clinical encounters will provide an epidemiology of the incidence of noninfectious and 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
The biorepository including self-collected samples will be catalogued and organized in a central location that can be easily accessed through a gatekeeper system.
Time frame: Up to 2 years
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