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.
Detailed description
The study is designed as a multicenter, prospective, non-randomized observational cohort. Eligible participants will be identified in thoracic surgery clinics, inpatient services, or routine postoperative follow-up programs at participating centers. After written informed consent, research blood samples of no more than 10 mL per time point will be collected together with routine clinical blood draws when available. No additional clinic visit, imaging examination, treatment, surgery, drug, device, vaccination, or other clinical intervention will be scheduled for research purposes. Peripheral blood will be analyzed using CyTOF mass cytometry to characterize major T-cell, B-cell, and NK-cell lineages, T-cell Naive/TCM/TEM/TEMRA differentiation, CD57-related senescence, activation markers, and immune checkpoint/exhaustion-related markers. Viral imprinting-related serology may include CMV IgG, EBV VCA-IgG, EBV EBNA-IgG, HPV L1-related antibodies, or other tests available within the approved institutional laboratory scope. Clinical and exposure data will be abstracted from routine records and study CRFs, including demographics, smoking and exposure history, relevant comorbidities, pulmonary nodule characteristics, pathology, imaging follow-up, and subsequent biopsy or surgery. Analyses will describe longitudinal immune phenotypes and evaluate exploratory associations between immune reserve, immune senescence, viral imprinting markers, and pulmonary nodule stability, enlargement, new nodule development, imaging risk upgrade, repeat biopsy, or repeat surgery. All research assay results are for group-level research only and will not be used to guide individual diagnosis, treatment, imaging interval, medication, or surgical decisions.
Interventions
None listed
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
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 in percentage from baseline in peripheral blood CyTOF-defined immune phenotype parameters | Baseline and routine follow-up visits through 24 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with pulmonary nodule evolution events assessed by routine chest CT | Baseline through 24 months | 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 | At each research blood collection visit from baseline through 24 months | — |
| Percentage of participants with positive CMV IgG measured by institutional immunoassay | Baseline | — |
| CyTOF assay completion rate | Baseline through 24 months | — |
| Research blood collection completion rate | Baseline through 24 months | — |
Contacts
CONTACTJianxing He
PRINCIPAL_INVESTIGATORJianxing
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed