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

NCT07647055 | Not Yet Recruiting

• 1 other identifier: ES-2025-266-288888
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Pulmonary Nodules

Keywords

CyTOF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• Research blood collection completion rate

  Baseline through 24 months

• Blood draw-related adverse events

  At each research blood collection visit from baseline through 24 months

• EBV VCA-IgG serostatus measured by institutional immunoassay

  Baseline

Study Arms (1)

Postoperative Multiple Pulmonary Nodule Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jianxing He

CONTACT

020-83062810; jianxinghe@gzhmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 15, 2026

Record last verified: 2026-05