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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT05250037
Status
Recruiting
Apply to this trial

Conditions

  • Bronchiolitis Obliterans Syndrome
  • Hematopoietic and Lymphoid Cell Neoplasm

Eligibility Criteria

Sex
ALL
Age
8 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 30, 2022
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: Screening (spirometry measurements)
    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.

Primary Outcome Measure

Incidence of bronchiolitis obliterans syndrome (BOS) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Stanford Cancer InstitutePalo AltoCalifornia94304
Joe Hsu, MD, MPH
[email protected]
650-724-7061
Joe Hsu, MD, MPH (PRINCIPAL_INVESTIGATOR)
Husham Sharifi, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan Cancer CenterAnn ArborMichigan48109
Maria Hollobaugh
[email protected]
734-647-6714
Greg Yanik, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Anum Waqar
[email protected]
713-834-9677
Ajay Sheshadri, MD (PRINCIPAL_INVESTIGATOR)
Amin Alousi, MD (PRINCIPAL_INVESTIGATOR)
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Guang-Shing Cheng, MD
[email protected]
206-667-7074
Guang-Shing Cheng, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Stanford Cancer Institute· Palo Alto, CAUniversity of Michigan Cancer Center· Ann Arbor, MIMD Anderson Cancer Center· Houston, TXFred Hutch/University of Washington Cancer Consortium· Seattle, WA

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