NCT05250037

The Longitudinal Impact of Respiratory Viruses on Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Cell Transplantation (The RV-BOS Study)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

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.)

Conditions

• Bronchiolitis Obliterans Syndrome
• Hematopoietic and Lymphoid Cell Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Home spirometry	Undergo spirometry measurements
PROCEDURE	Biospecimen Collection	Undergo nasal and/or oral swabs, and blood collection
OTHER	Questionnaire Administration	Complete questionnaires

Timeline

• Start date: 2022-03-30
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2022-02-22
• Last updated: 2026-01-08

Locations

4 sites across 1 country: United States