The Longitudinal Impact of Respiratory Viruses on Bronchiolitis Obliterans Syndrome After Allogen… (NCT05250037) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Longitudinal Impact of Respiratory Viruses on Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Cell Transplantation (The RV-BOS Study)
United States261 participantsStarted 2022-03-30
Plain-language 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.
Who can participate
Age range
8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. A diagnosis of cGVHD as per NIH criteria through 5 years of diagnosis.
. At 'Day 80' evaluation. D80 designates a posttransplant landmark, usually between 70-120 days, in which patients are evaluated for discharge back to community care. Patients with the following occurrences can be enrolled with 3 months of the Day 80 post-transplant evaluation.
. "Early BOS", ie patients with new airflow decline and obstruction, not yet meeting the FEV1 cut-off of \< 75% predicted by FEV1, in the absence of other etiologies as determined by clinical investigations including chest imaging and microbiologic studies.
. NIH-defined BOS:
. BOS with atypical spirometric pattern
. Clinical or suspected diagnosis of BOS not otherwise meeting above criteria.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is looking at how respiratory viruses might contribute to bronchiolitis obliterans syndrome after a stem cell transplant — given my situation, is tracking my lung function and viral infections over time something my care team is already doing, or is this study the best way to make sure that monitoring happens?
2Since this trial is 'active but not recruiting,' does that mean I've missed the chance to participate, and if so, are there other similar observational studies at your center that could give me access to the same kind of close respiratory monitoring?
3The study is measuring pulmonary impairment as a key outcome — what early warning signs of BOS should I be watching for after my transplant, and how often should my lung function be tested regardless of whether I'm in this study?
4Since this is an observational study rather than a treatment trial, what does my care team currently recommend to prevent or manage BOS if respiratory viruses do turn out to be a trigger for it in my case?
5Given that BOS is one of the conditions this study focuses on, how concerned should I be about my personal risk of developing it after my transplant, and what factors in my history would make that risk higher or lower?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of bronchiolitis obliterans syndrome (BOS)