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

A Single-Center Prospective Cohort Study of Peripheral Blood CyTOF Immune Phenotyping and Viral Imprinting in Patients With 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Pulmonary Nodules

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jianxing He; Phone Number: 020-83062810; Email: jianxinghe@gzhmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults who have undergone surgical resection of a primary pulmonary nodule and have residual multiple pulmonary nodules or require routine postoperative pulmonary nodule follow-up at participating centers. Participants will be identified from thoracic surgery clinics, inpatient services, and routine postoperative follow-up programs. Eligible participants will provide written informed consent and will be followed according to usual clinical care; research blood samples and study data will be collected at clinically scheduled visits when routine blood draws and follow-up data are available.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Postoperative Multiple Pulmonary Nodule Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in percentage of peripheral blood CD8+ CD57+ T cells measured by CyTOF	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.	Baseline and routine follow-up blood collections through 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood draw-related adverse events	At each research blood collection visit from baseline through 24 months
CyTOF assay completion rate	Baseline through 24 months
Research blood collection completion rate	Baseline through 24 months
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
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: CyTOF
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: ES-2025-266-288888

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No