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.
Study Type
OBSERVATIONAL
Enrollment
200
Change from baseline in percentage of peripheral blood CD8+ CD57+ T cells measured by CyTOF
CyTOF mass cytometry will measure percentages of CD4+ T cells, CD8+ T cells, B cells, NK cells, Naive/TCM/TEM/TEMRA subsets, CD57-positive cells, HLA-DR/CD38-positive cells, and PD-1/CTLA-4/TIM-3/TIGIT-positive cells. The outcome is the change from baseline in each prespecified percentage or marker-positive frequency.
Time frame: Baseline and routine follow-up blood collections through 24 months
Number and percentage of participants with pulmonary nodule evolution events assessed by routine chest CT
Time frame: Baseline through 24 months
CMV IgG serostatus measured by institutional immunoassay
Time frame: Baseline
Research blood collection completion rate
Time frame: Baseline through 24 months
Blood draw-related adverse events
Time frame: At each research blood collection visit from baseline through 24 months
EBV VCA-IgG serostatus measured by institutional immunoassay
Time frame: Baseline
EBV EBNA-IgG serostatus measured by institutional immunoassay
Time frame: Baseline
HPV L1 antibody serostatus measured by institutional immunoassay
Time frame: Baseline
CyTOF assay completion rate
Time frame: Baseline through 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.