[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05250037":3,"trial-entities:NCT05250037":136,"trial-summary:NCT05250037":139},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":47,"secondary_outcomes":55,"sex":71,"minimum_age":72,"maximum_age":14,"healthy_volunteers":73,"eligibility_criteria":74,"std_ages":91,"locations":95,"central_contacts":129,"overall_officials":130,"references":134,"see_also_links":135},"NCT05250037","RG1121806","The Longitudinal Impact of Respiratory Viruses on Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Cell Transplantation (The RV-BOS Study)","ACTIVE_NOT_RECRUITING","2028-12-31","2026-07","2026-07-27","2022-03-30","Fred Hutchinson Cancer Center","OTHER",null,"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:\n\nThis is an observational study.\n\nPatients 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. (The minimum required follow-up is 1 year, but there is an optional 1 year extension period.)",[18,19],"Bronchiolitis Obliterans Syndrome","Hematopoietic and Lymphoid Cell Neoplasm",[],"OBSERVATIONAL",[],{"count":24,"type":25},261,"ACTUAL",[27,35,43],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":33},"PROCEDURE","Home spirometry","Undergo spirometry measurements",[32],"Screening (spirometry measurements)",[34],"SPIROMETRY",{"type":28,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Biospecimen Collection","Undergo nasal and\u002For oral swabs, and blood collection",[32],[40,41,42],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":13,"name":44,"description":45,"armGroupLabels":46},"Questionnaire Administration","Complete questionnaires",[32],[48,52],{"measure":49,"description":50,"timeFrame":51},"Incidence of bronchiolitis obliterans syndrome (BOS)","Diagnosed by National Institute of Health criteria or clinical diagnosis in the absence of alternative diagnosis.","Up to 2 years",{"measure":53,"description":54,"timeFrame":51},"Pulmonary impairment","Defined by temporal decline in forced expiratory volume in the first second (FEV1) determined by assessment of spirometry data.",[56,58,60,63,66,68],{"measure":57,"timeFrame":51},"Time from respiratory viral infection and chronic graft-versus-host disease to FEV1 decline",{"measure":59,"timeFrame":51},"FEV1 (percent predicted) at clinical recognition of BOS",{"measure":61,"description":62,"timeFrame":51},"Incidence of asymptomatic and symptomatic viral infections","Will be determined by the longitudinal follow-up of this observational study.",{"measure":64,"description":65,"timeFrame":51},"Incidence of late onset noninfectious pulmonary complications","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.",{"measure":67,"description":65,"timeFrame":51},"Incidence of non-viral infectious pulmonary complications",{"measure":69,"description":70,"timeFrame":51},"Establishment of a biorepository that includes blood samples, respiratory viral samples, and nasal microbiome samples from patients with clinically recognized BOS","The biorepository including self-collected samples will be catalogued and organized in a central location that can be easily accessed through a gatekeeper system.","ALL","8 Years",false,{"inclusion":75,"exclusion":82,"raw_text":90},[76,77,78,79,80,81],"Allogeneic HCT recipients with any indication, graft source, donor type, or conditioning regimen","Age 8 and older","a. Evidence of air trapping by PFTs: RV\\>120%, or elevated RV\u002FTLC (\\>20% of predicted value)","b. High resolution chest CT with inspiratory and expiratory cuts that show findings that are consistent with small airways disease including (but not exclusive of) air trapping, bronchial wall thickening, or bronchiectasis. 3. BOS with atypical spirometric pattern","Patient should have an Android or iOS-based smartphone with reliable access to Wi-Fi for data to be transmitted electronically. Android smartphones should have a software version of 4.0 or higher; iOS phones should have a version of 8.0 or higher.","Patient should be willing and able to communicate electronically in English or Spanish.",[83,84,85,86,87,88,89],"Diagnosis of BOS at time of enrollment (Cohort 1 only)","Life expectancy \\\u003C 2 years.","Diagnosis of active hematologic relapse or malignancy requiring active treatment that will affect that patient's ability to comply with study procedures.","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.","Inability or unwillingness to perform the study procedures, most of which are performed at home.","Lack of a personal iOS or Android smartphone.","Inability or unwillingness to communicate electronically.","Inclusion Criteria:\n\n* Allogeneic HCT recipients with any indication, graft source, donor type, or conditioning regimen\n* Age 8 and older\n* COHORT 1 Inclusion criteria: One or more of the following clinical scenarios that encompass increased risk for BOS:\n\n  1. A diagnosis of cGVHD as per NIH criteria through 5 years of diagnosis.\n\n     i. New diagnosis of cGVHD within 3 months. This window may be extended by 30 days on a case-by-case basis.\n\n     ii. A diagnosis of cGVHD ≥ 3 months and ≤ 5 years, with a new FEV1 decline of ≥10% in absolute value within 6 weeks compared with PFT done within the prior 2 years.\n\n     iii. A recent documented respiratory infection of any etiology that has been clinically managed and stabilized or improving as determined by a clinician, within 8 weeks.\n\n     iv. Progression of flare of chronic GVHD requiring an alteration in therapy as determined by a clinician, within 3 months.\n  2. 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.\n\n     i. FEV1 decline of 10% in absolute values compared with pretransplant baseline. ii. Documented posttransplant RVI. iii. Lower respiratory tract disease (LRTD) of any etiology.\n* COHORT 2 inclusion criteria: Newly diagnosed BOS within 6 weeks of clinical recognition. This may include the following scenarios:\n\n  1. \"Early BOS\", ie patients with new airflow decline and obstruction, not yet meeting the FEV1 cut-off of \\\u003C 75% predicted by FEV1, in the absence of other etiologies as determined by clinical investigations including chest imaging and microbiologic studies.\n  2. NIH-defined BOS:\n\n     i. FEV1 \\\u003C 75% predicted, with a decline in absolute FEV1 \\> 10% compared to pretransplant baseline or within the prior 2 years. Absolute decline in FEV1 should remain \\>10% after bronchodilator response.\n\n     ii. FEV1\u002FFVC or FEV1\u002FVC \\\u003C0.7, or Lower Limit of Normal as per accepted reference standards. Reference standards may include National Health and Nutrition Examination Survey III or Global Lung Initiative.\n\n     iii. Absence of an alternative diagnosis, including COPD exacerbation, asthma, and active respiratory tract infection, as determined by appropriate clinical investigations that may include chest imaging, microbiologic cultures, and\u002For bronchoscopy.\n\n     iv. One of two supportive features of BOS:\n     * a. Evidence of air trapping by PFTs: RV\\>120%, or elevated RV\u002FTLC (\\>20% of predicted value)\n     * b. High resolution chest CT with inspiratory and expiratory cuts that show findings that are consistent with small airways disease including (but not exclusive of) air trapping, bronchial wall thickening, or bronchiectasis.\n  3. BOS with atypical spirometric pattern\n\n     i. FEV1 \\\u003C80%, with a preserved FEV1\u002FFVC ratio (≥0.7) and TLC ≥80% in the absence of other clinically determined lung disease.\n  4. Clinical or suspected diagnosis of BOS not otherwise meeting above criteria.\n* Patient should have an Android or iOS-based smartphone with reliable access to Wi-Fi for data to be transmitted electronically. Android smartphones should have a software version of 4.0 or higher; iOS phones should have a version of 8.0 or higher.\n* Patient should be willing and able to communicate electronically in English or Spanish.\n\nExclusion Criteria:\n\n* Diagnosis of BOS at time of enrollment (Cohort 1 only)\n* Life expectancy \\\u003C 2 years.\n* Diagnosis of active hematologic relapse or malignancy requiring active treatment that will affect that patient's ability to comply with study procedures.\n* 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.\n* Inability or unwillingness to perform the study procedures, most of which are performed at home.\n* Lack of a personal iOS or Android smartphone.\n* Inability or unwillingness to communicate electronically.",[92,93,94],"CHILD","ADULT","OLDER_ADULT",[96,105,113,121],{"facility":97,"city":98,"state":99,"zip":100,"country":101,"geoPoint":102},"Stanford Cancer Institute","Palo Alto","California","94304","United States",{"lat":103,"lon":104},37.44188,-122.14302,{"facility":106,"city":107,"state":108,"zip":109,"country":101,"geoPoint":110},"University of Michigan Cancer Center","Ann Arbor","Michigan","48109",{"lat":111,"lon":112},42.27756,-83.74088,{"facility":114,"city":115,"state":116,"zip":117,"country":101,"geoPoint":118},"MD Anderson Cancer Center","Houston","Texas","77030",{"lat":119,"lon":120},29.76328,-95.36327,{"facility":122,"city":123,"state":124,"zip":125,"country":101,"geoPoint":126},"Fred Hutch\u002FUniversity of Washington Cancer Consortium","Seattle","Washington","98109",{"lat":127,"lon":128},47.60621,-122.33207,[],[131],{"name":132,"affiliation":122,"role":133},"Guang-Shing Cheng, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":137,"biomarkers":138},[18,19],[],{"nct_id":4,"found":140,"summary":141,"prompt_version":151},true,{"design":142,"status":143,"heading":144,"summary":145,"follow_up":146,"word_count":147,"commitments":148,"compensation":149,"drugs_mentioned":150},"This is an observational study with a planned enrollment of 261 participants. It is not a treatment study but rather aims to understand the connection between viruses and lung disease.","completed","Observational Study on Respiratory Viruses and Lung Disease After Transplant","This observational study, called The RV-BOS Study, is looking into how respiratory viruses might lead to a lung condition called bronchiolitis obliterans syndrome (BOS) or lung graft-versus-host disease in patients who have had a stem cell transplant. Patients with chronic graft-versus-host disease (cGVHD) are at higher risk for BOS. Researchers are also interested in how early respiratory viral illnesses after transplant might affect lung health later on. The study will involve home spirometry (a test to measure lung function), collecting nasal\u002Foral swabs and blood samples, and filling out questionnaires. The main goals are to see how often BOS occurs and to track changes in lung function over up to two years. This study is for people aged 8 and older who have received an allogeneic hematopoietic cell transplant.","Participants will be followed for up to 2 years to track the incidence of bronchiolitis obliterans syndrome and pulmonary impairment.",128,"You would perform home spirometry and complete questionnaires weekly, provide a nasal swab every 4 weeks, and give blood samples and nasal swabs every 3 months for up to 2 years.","Not stated in the trial record.",[29],"v2"]