Clinical trial · Observational

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

NCT07647055CI-TRIAL-00114713not yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

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

No intervention recorded.

Design

Arms and outcomes

Arms (1)

label
Postoperative Multiple Pulmonary Nodule Cohort

Primary outcomes (1)

measure
Change from baseline in percentage of peripheral blood CD8+ CD57+ T cells measured by CyTOF
timeFrame
Baseline and routine follow-up blood collections through 24 months
description
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 (8)

measure
Number and percentage of participants with pulmonary nodule evolution events assessed by routine chest CT
timeFrame
Baseline through 24 months
measure
CMV IgG serostatus measured by institutional immunoassay

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

No reference posted for this study.