Clinical trial · Observational
Peripheral Blood CyTOF and Viral Imprinting in Postoperative Multiple Pulmonary Nodules
A Multicenter Prospective Cohort Study of Peripheral Blood CyTOF Immune Phenotyping and Viral Imprinting in Patients With Postoperative Multiple Pulmonary Nodules
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Pulmonary Nodules | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Postoperative Multiple Pulmonary Nodule Cohort
- description
- Adults with a resected primary pulmonary nodule who have residual multiple pulmonary nodules or require pulmonary nodule-related routine postoperative follow-up at participating centers. Participants will be followed according to routine clinical care, and research samples/data will be collected at clinically scheduled visits.
Primary outcomes (1)
- measure
- Change in percentage from baseline in peripheral blood CyTOF-defined immune phenotype parameters
- timeFrame
- Baseline and routine follow-up visits through 24 months
- description
- 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 (5)
- measure
- Percentage of participants with pulmonary nodule evolution events assessed by routine chest CT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available