Actively Recruiting
The Longitudinal Impact of Respiratory Viruses on Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Cell Transplantation (The RV-BOS Study)
Led by Fred Hutchinson Cancer Center ยท Updated on 2026-05-11
250
Participants Needed
4
Research Sites
26 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether respiratory viruses cause lung diseases like bronchiolitis obliterans syndrome (BOS) or lung graft-versus-host disease in patients who have received donor stem cell transplants. Patients with chronic graft-versus-host disease (cGVHD) have a higher risk of BOS, and early respiratory viral illnesses after transplant may increase the chance of later lung problems. Monitoring lung function closely could benefit at-risk patients or those who already have BOS. Participants will use a handheld spirometer at home to measure lung function weekly and complete questionnaires. Every four weeks, they will provide nasal swabs for viral testing, and every three months, blood samples and nasal swabs will be collected. This monitoring will continue for up to two years, with at least one year required, plus an optional one-year extension. During the study, participants will regularly perform lung function tests at home, submit samples for viral and blood analysis, and complete health questionnaires. Researchers will track the occurrence of BOS and lung impairment, measure lung function decline, and study viral infections over time. The study aims to better understand lung disease development after transplant and improve early detection through home monitoring.
CONDITIONS
Brief Title
The Longitudinal Impact of Respiratory Viruses on Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Cell Transplantation (The RV-BOS Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Allogeneic hematopoietic cell transplant recipients of any age 8 years or older
- Patients with chronic graft-versus-host disease (cGVHD) within 5 years of diagnosis or increased risk for bronchiolitis obliterans syndrome (BOS)
- Patients at Day 80 posttransplant with lung function decline or respiratory viral infection
- Newly diagnosed BOS within 6 weeks of clinical recognition
- Ability to use an Android or iOS smartphone with Wi-Fi
- Willing and able to communicate electronically in English or Spanish
You will not qualify if you...
- Diagnosis of BOS at time of enrollment for Cohort 1
- Life expectancy less than 2 years
- Active blood cancer relapse or malignancy requiring treatment that interferes with study
- Acute active lower respiratory tract infection or noninfectious respiratory condition at enrollment
- Inability or unwillingness to perform study procedures at home
- No personal iOS or Android smartphone
- Unable or unwilling to communicate electronically
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Up to 2 years
Participants perform weekly home spirometry measurements and complete weekly questionnaires to monitor lung function and symptoms.
Weekly home measurements and questionnaires
Duration - Up to 2 years
Participants undergo nasal swabs every 4 weeks for viral polymerase chain reaction (PCR) surveillance to detect respiratory viruses.
Nasal swabs every 4 weeks
Duration - Up to 2 years
Participants provide blood samples and nasal swabs every 3 months for further analysis related to lung health and viral infections.
Blood and nasal swab collection every 3 months
Trial Site Locations
Total: 4 locations
1
Stanford Cancer Institute
Palo Alto, California, United States, 94304
Actively Recruiting
2
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
4
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
G
Guang-Shing Cheng, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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