Single-Center CyTOF and Viral Imprinting Study in Postoperative Multiple Pulmonary Nodules
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Multiple Pulmonary Nodules. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-Center Prospective Cohort Study of Peripheral Blood CyTOF Immune Phenotyping and Viral Imprinting in Patients With Postoperative Multiple Pulmonary Nodules
Overview
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.
Primary outcome measures
- Change from baseline in percentage of peripheral blood CD8+ CD57+ T cells measured by CyTOF [Time frame: Baseline and routine follow-up blood collections through 24 months]
Secondary outcome measures (8)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07647055 · ES-2025-266-288888