250 Participants Needed

Respiratory Viruses for Blood Cancers

(RV-BOS Trial)

Recruiting at 3 trial locations
GC
GC
Overseen ByGuang-Shing Cheng
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Fred Hutchinson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if respiratory viruses cause lung disease in individuals who have received a donor stem cell transplant. The primary focus is on bronchiolitis obliterans syndrome (BOS), a lung condition that can develop after a transplant. Participants will use a simple handheld device for spirometry (a test to measure lung function) at home, potentially aiding in the earlier diagnosis and treatment of lung issues. Individuals who have had a donor stem cell transplant and are at risk for BOS, particularly those who have experienced graft-versus-host disease or recent lung infections, may be suitable for this trial. Participants need a smartphone to share their health data electronically.

As an unphased trial, this study provides a unique opportunity for participants to contribute to groundbreaking research that could lead to earlier diagnosis and treatment of lung issues post-transplant.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that spirometry is safe for monitoring lung function at home?

Research shows that spirometry is a safe and easy procedure. It measures lung function using a small handheld device. Studies have found it to be generally safe, although some people might feel slightly short of breath or dizzy immediately after the test. This is normal and usually resolves quickly. Spirometry has been used for many years in various health programs, proving it is a reliable and safe method for checking lung health.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of home spirometry to monitor respiratory health in patients with Bronchiolitis Obliterans Syndrome after a stem cell transplant. Unlike traditional methods that require frequent hospital visits, this approach uses a portable handheld spirometer, allowing patients to perform lung function tests conveniently at home. This could lead to earlier detection of issues, more personalized treatment plans, and ultimately, improved outcomes for patients. Additionally, regular nasal swabs and blood collections help track viral infections, which could provide insights into preventing or managing complications.

What evidence suggests that spirometry is effective for monitoring lung function in patients with BOS?

Research shows that spirometry, a simple breathing test, helps track lung health and diagnose lung infections. Studies have found that spirometry can identify breathing problems in individuals who have experienced illnesses like COVID-19. By revealing changes in lung performance, it helps detect lung issues early. In this trial, participants will use a handheld spirometer for home spirometry measurements, potentially identifying diseases like bronchiolitis obliterans syndrome (a type of lung disease) sooner. This is particularly important for patients who have received a donor stem cell transplant and are at risk for lung problems.678910

Who Is on the Research Team?

GC

Guang-Shing Cheng, MD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

Inclusion Criteria

i. "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.
Allogeneic HCT recipients with any indication, graft source, donor type, or conditioning regimen
Age 8 and older
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Participants undergo home spirometry measurements with a portable handheld spirometer and complete questionnaires weekly, a nasal swab for viral PCR surveillance every 4 weeks, and undergo blood collection and nasal swabs every 3 months

Up to 2 years

Follow-up

Participants are monitored for the incidence of late onset noninfectious pulmonary complications and other outcomes

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Respiratory Virus Testing
  • Spirometry

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Screening (spirometry measurements)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials
583
Recruited
1,341,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

Clinical features and outcomes of viral respiratory infections in ...

In this context, our study aimed to compare the clinical characteristics and hospitalization risks associated with the major respiratory viruses ...

Post-discharge spirometry evaluation in patients ...

This study highlights that patients recovering from moderate-to-critical COVID-19 often exhibit abnormal spirometry, notably a restrictive pattern and PRISm.

Respiratory viral infections: when and where? A scoping ...

Respiratory viral infections pose a substantial disease burden worldwide. Spatiotemporal techniques help identify transmission patterns of these ...

What diagnostic tests are available for respiratory ...

Spirometry tests, indicating lung function, facilitate respiratory infection diagnoses. There is no clear definition of what an exacerbation is in persons with ...

How spirometry can help manage lung infections

Spirometry can be a valuable tool in managing lung infections, by providing detailed information on lung function and tracking a patient's ...

Spirometry Testing in Occupational Health Programs

OSHA standards for asbestos, cadmium, coke oven emissions, and cotton dust require spirometry testing as part of medical surveillance. (see 29 CFR 1910.1001, ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28663340/

Safety of pulmonary function testing: data from 20 years

Routine and specialised PFT is safe for patients, in the context of established screening preparticipation guidelines.

HHE Report No. HETA-2008-0155-3131, Lung Function ( ...

They should have follow up spirometry testing at 3 month intervals at least until their lung function has stabilized.

Spirometry

Spirometry is generally a safe test. You may feel short of breath or dizzy for a moment after you do the test. Because the test requires some ...

Spirometry in Occupational Health—2020 - ACOEM

Longitudinal evaluations of peri- odic spirometry testing may detect exces- sive lung function loss due to an exposure or underlying condition ...

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