Symptoms and General Pathology

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Respiratory Tract (Lung and Bronchial) Diseases

Immune System Diseases

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Syndrome

Bronchiolitis

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Bronchiolitis Obliterans Syndrome

Bronchiolitis Obliterans

Bronchitis

Communicable Diseases

Respiratory Tract Infections

Bronchial Diseases

Respiratory Tract Diseases

Lung Diseases, Obstructive

Lung Diseases

Pneumonia

Organizing Pneumonia

Graft vs Host Disease

Bronchiolitis Obliterans Organizing Pneumonia

Homologous Wasting Disease

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.

Home spirometry

Undergo nasal and/or oral swabs, and blood collection

Biospecimen Collection

Questionnaire Administration

Guang-Shing Cheng, MD

Joe Hsu, MD, MPH

Husham Sharifi, MD

Connie Varner

Greg Yanik, MD

Luis Vaquero

Ajay Sheshadri, MD

Amin Alousi, MD

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.

Whole blood, plasma, serum, PBMC and nasal swabs.

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

Diagnosed by National Institute of Health criteria or clinical diagnosis in the absence of alternative diagnosis.

Defined by temporal decline in forced expiratory volume in the first second (FEV1) determined by assessment of spirometry data.

Will be determined by the longitudinal follow-up of this observational study.

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.

The biorepository including self-collected samples will be catalogued and organized in a central location that can be easily accessed through a gatekeeper system.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Longitudinal Impact of Respiratory Viruses on Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Cell Transplantation (The RV-BOS Study)	NCT05250037	Bronchiolitis O... Hematopoietic a...	Home spirometry Biospecimen Col... Questionnaire A...	8 Years -	Fred Hutchinson Cancer Center
The Longitudinal Impact of Respiratory Viruses on Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Cell Transplantation (The RV-BOS Study)	NCT05250037	Bronchiolitis O... Hematopoietic a...	Home spirometry Biospecimen Col... Questionnaire A...	8 Years -	Fred Hutchinson Cancer Center

Spots Global Cancer Trial Database for home spirometry