About this trial
This multicenter prospective cohort study will enroll adults who have undergone resection of a primary pulmonary nodule and have residual multiple pulmonary nodules or require routine postoperative pulmonary nodule follow-up. During clinically indicated follow-up visits, a small amount of peripheral venous blood will be collected at the same time as routine blood draws for research CyTOF immune phenotyping and viral imprinting-related serology. The study will not assign participants to treatment, change follow-up schedules, imaging, medication, surgery, or other clinical care. Research laboratory results will not be returned to participants or entered into medical records. The study will describe longitudinal peripheral immune-cell profiles and explore associations among T/B/NK cell phenotypes, T-cell differentiation and senescence/exhaustion markers, viral imprinting markers, and postoperative residual or new pulmonary nodule evolution.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Adults who have undergone surgical resection of a primary pulmonary nodule and have residual multiple pulmonary nodules or require routine postoperative pulmonary nodule follow-up at participating centers. Participants will be identified from thoracic surgery clinics, inpatient services, and routine postoperative follow-up programs. Eligible participants will provide written informed consent and will be followed according to usual clinical care; research blood samples and study data will be collected at clinically scheduled visits when routine blood draws and follow-up data are available.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in percentage from baseline in peripheral blood CyTOF-defined immune phenotype parameters
Change in percentage of major immune-cell lineages and predefined T-cell differentiation/senescence/activation/exhaustion parameters, including CD4+ T cells, CD8+ T cells, B cells, NK cells, Naive/TCM/TEM/TEMRA subsets, CD57-related phenotypes, HLA-DR/CD38 activation markers, and PD-1/CTLA-4/TIM-3/TIGIT-related checkpoint expression, reported as percentages of parent populations and/or marker-positive frequencies.
Secondary outcomes
Percentage of participants with pulmonary nodule evolution events assessed by routine chest CT
percentage of participants with postoperative residual or new pulmonary nodule evolution, including stable disease, nodule enlargement, new nodule development, increase in solid component, imaging risk upgrade, repeat biopsy, or repeat surgery, as recorded in routine clinical imaging and medical records.
Blood draw-related adverse events
Percentage of participants with positive CMV IgG measured by institutional immunoassay
CyTOF assay completion rate
Locations
Sponsors and contacts
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