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NCT Number: NCT07647055

Single-Center CyTOF and Viral Imprinting Study in Postoperative Multiple Pulmonary Nodules

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.

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Key information

Conditions

Multiple Pulmonary Nodules Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

    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 outcomes

  1. Number and percentage of participants with pulmonary nodule evolution events assessed by routine chest CT

    Time frame: Baseline through 24 months

  2. CMV IgG serostatus measured by institutional immunoassay

    Time frame: Baseline

  3. Research blood collection completion rate

    Time frame: Baseline through 24 months

  4. Blood draw-related adverse events

    Time frame: At each research blood collection visit from baseline through 24 months

  5. EBV VCA-IgG serostatus measured by institutional immunoassay

    Time frame: Baseline

  6. EBV EBNA-IgG serostatus measured by institutional immunoassay

    Time frame: Baseline

  7. HPV L1 antibody serostatus measured by institutional immunoassay

    Time frame: Baseline

  8. CyTOF assay completion rate

    Time frame: Baseline through 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jianxing He

CONTACT

[email protected]

020-83062810

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

A Single-Center Prospective Cohort Study of Peripheral Blood CyTOF Immune Phenotyping and Viral Imprinting in Patients With Postoperative Multiple Pulmonary Nodules

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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