Peripheral Blood CyTOF and Viral Imprinting in Postoperative Multiple Pulmonary Nodules

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Guangzhou Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Postoperative Multiple Pulmonary Nodule Cohort

Trial outcomes

Primary outcomes

1

Change in percentage from baseline in peripheral blood CyTOF-defined immune phenotype parameters

Change in percentage of major immune-cell lineages and predefined T-cell differentiation/senescence/activation/exhaustion parameters, including CD4+ T cells, CD8+ T cells, B cells, NK cells, Naive/TCM/TEM/TEMRA subsets, CD57-related phenotypes, HLA-DR/CD38 activation markers, and PD-1/CTLA-4/TIM-3/TIGIT-related checkpoint expression, reported as percentages of parent populations and/or marker-positive frequencies.

Time frame
Baseline and routine follow-up visits through 24 months

Secondary outcomes

1

Percentage of participants with pulmonary nodule evolution events assessed by routine chest CT

percentage of participants with postoperative residual or new pulmonary nodule evolution, including stable disease, nodule enlargement, new nodule development, increase in solid component, imaging risk upgrade, repeat biopsy, or repeat surgery, as recorded in routine clinical imaging and medical records.

Time frame
Baseline through 24 months
2

Blood draw-related adverse events

Time frame
At each research blood collection visit from baseline through 24 months
3

Percentage of participants with positive CMV IgG measured by institutional immunoassay

Time frame
Baseline
4

CyTOF assay completion rate

Time frame
Baseline through 24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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