RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-30
Study Completion:2028-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05250037

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Allogeneic HCT recipients with any indication, graft source, donor type, or conditioning regimen
  2. * Age 8 and older
  3. * COHORT 1
  1. * Life expectancy \< 2 years.
  2. * Diagnosis of active hematologic relapse or malignancy requiring active treatment that will affect that patient's ability to comply with study procedures.
  3. * Patient should not have a clinically acute active lower respiratory tract infection or a clinically acute active noninfectious respiratory condition (i.e. COPD exacerbation, pleural effusion) at the time of enrollment. However, patient may become eligible once these conditions have stabilized or resolved as noted above.
  4. * Inability or unwillingness to perform the study procedures, most of which are performed at home.
  5. * Lack of a personal iOS or Android smartphone.
  6. * Inability or unwillingness to communicate electronically.

Contacts and Locations

Study Contact

Guang-Shing Cheng, MD
CONTACT
206.667.7074
gcheng2@fredhutch.org

Principal Investigator

Guang-Shing Cheng, MD
PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium

Study Locations (Sites)

Stanford Cancer Institute
Palo Alto, California, 94304
United States
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Fred Hutchinson Cancer Center

  • Guang-Shing Cheng, MD, PRINCIPAL_INVESTIGATOR, Fred Hutch/University of Washington Cancer Consortium

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-30
Study Completion Date2028-06-30

Study Record Updates

Study Start Date2022-03-30
Study Completion Date2028-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Bronchiolitis Obliterans Syndrome
  • Hematopoietic and Lymphoid Cell Neoplasm