Multiple Pulmonary Nodules
Conditions
Keywords
CyTOF
Brief summary
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.
Interventions
None listed
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older, any sex. Primary pulmonary nodule has been surgically resected, with residual multiple pulmonary nodules or a need for pulmonary nodule-related routine postoperative follow-up. Planned routine postoperative follow-up at a participating center and able to provide a research blood sample together with routine blood draw when clinically available. Able to understand the study and willing to provide written informed consent before research blood sample collection.
Exclusion criteria
* Investigator judges that the participant is unsuitable for additional small-volume blood collection, such as severe anemia, obvious coagulation abnormality, recent severe bleeding, or high risk of severe vasovagal reaction. Acute severe infection, acute major organ dysfunction, or other condition that may substantially affect peripheral immune status and makes study participation unsuitable. Current strong immunosuppressive therapy that may substantially affect peripheral immune status and cannot be adequately recorded or adjusted for in analysis. Unable to complete informed consent or explicitly refuses use of research blood samples and related data for this study. Any other condition that, in the investigator's judgment, makes participation inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in percentage of peripheral blood CD8+ CD57+ T cells measured by CyTOF | Baseline and routine follow-up blood collections through 24 months | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Number and percentage of participants with pulmonary nodule evolution events assessed by routine chest CT | Baseline through 24 months |
| CMV IgG serostatus measured by institutional immunoassay | Baseline |
| Research blood collection completion rate | Baseline through 24 months |
| Blood draw-related adverse events | At each research blood collection visit from baseline through 24 months |
| EBV VCA-IgG serostatus measured by institutional immunoassay | Baseline |
| EBV EBNA-IgG serostatus measured by institutional immunoassay | Baseline |
| HPV L1 antibody serostatus measured by institutional immunoassay | Baseline |
| CyTOF assay completion rate | Baseline through 24 months |
Contacts
CONTACTJianxing He
Outcome results
None listed