The Longitudinal Impact of Respiratory Viruses on Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Cell Transplantation (The RV-BOS Study)
Fred Hutchinson Cancer Center
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.
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.)
Eligibility
- Age range
- 8+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Allogeneic HCT recipients with any indication, graft source, donor type, or conditioning regimen * Age 8 and older * COHORT 1 Inclusion criteria: One or more of the following clinical scenarios that encompass increased risk for BOS: 1. A diagnosis of cGVHD as per NIH criteria through 5 years of diagnosis. i. New diagnosis of cGVHD within 3 months. This window may be extended by 30 days on a case-by-case basis. ii. A diagnosis of cGVHD ≥ 3 months ≤ 5 years with a new FEV1 decline of ≥10% in absolute compared with prior 2 years PFT. iii. A recent docum…
Interventions
- ProcedureHome spirometry
Undergo spirometry measurements
- ProcedureBiospecimen Collection
Undergo nasal and/or oral swabs, and blood collection
- OtherQuestionnaire Administration
Complete questionnaires
Locations (4)
- Stanford Cancer InstitutePalo Alto, California
- University of Michigan Cancer CenterAnn Arbor, Michigan
- MD Anderson Cancer CenterHouston, Texas
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington