Peripheral Blood CyTOF and Viral Imprinting in Postoperative Multiple Pulmonary Nodules
2026年6月12日 更新者：Jianxing He、The First Affiliated Hospital of Guangzhou Medical University
A Multicenter 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.
研究概览
地位
尚未招聘
条件
详细说明
The study is designed as a multicenter, prospective, non-randomized observational cohort.
Eligible participants will be identified in thoracic surgery clinics, inpatient services, or routine postoperative follow-up programs at participating centers.
After written informed consent, research blood samples of no more than 10 mL per time point will be collected together with routine clinical blood draws when available.
No additional clinic visit, imaging examination, treatment, surgery, drug, device, vaccination, or other clinical intervention will be scheduled for research purposes.
Peripheral blood will be analyzed using CyTOF mass cytometry to characterize major T-cell, B-cell, and NK-cell lineages, T-cell Naive/TCM/TEM/TEMRA differentiation, CD57-related senescence, activation markers, and immune checkpoint/exhaustion-related markers.
Viral imprinting-related serology may include CMV IgG, EBV VCA-IgG, EBV EBNA-IgG, HPV L1-related antibodies, or other tests available within the approved institutional laboratory scope.
Clinical and exposure data will be abstracted from routine records and study CRFs, including demographics, smoking and exposure history, relevant comorbidities, pulmonary nodule characteristics, pathology, imaging follow-up, and subsequent biopsy or surgery.
Analyses will describe longitudinal immune phenotypes and evaluate exploratory associations between immune reserve, immune senescence, viral imprinting markers, and pulmonary nodule stability, enlargement, new nodule development, imaging risk upgrade, repeat biopsy, or repeat surgery.
All research assay results are for group-level research only and will not be used to guide individual diagnosis, treatment, imaging interval, medication, or surgical decisions.
研究类型
观察性的
注册 (估计的)
200
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jianxing He
- 电话号码：020-83062810
- 邮箱：jianxinghe@gzhmu.edu.cn
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
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.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Postoperative Multiple Pulmonary Nodule Cohort
Adults with a resected primary pulmonary nodule who have residual multiple pulmonary nodules or require pulmonary nodule-related routine postoperative follow-up at participating centers.
Participants will be followed according to routine clinical care, and research samples/data will be collected at clinically scheduled visits.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in percentage from baseline in peripheral blood CyTOF-defined immune phenotype parameters
大体时间：Baseline and routine follow-up visits through 24 months
|
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.
|
Baseline and routine follow-up visits through 24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of participants with pulmonary nodule evolution events assessed by routine chest CT
大体时间：Baseline through 24 months
|
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.
|
Baseline through 24 months
|
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Blood draw-related adverse events
大体时间：At each research blood collection visit from baseline through 24 months
|
At each research blood collection visit from baseline through 24 months
|
|
|
Percentage of participants with positive CMV IgG measured by institutional immunoassay
大体时间：Baseline
|
Baseline
|
|
|
CyTOF assay completion rate
大体时间：Baseline through 24 months
|
Baseline through 24 months
|
|
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Research blood collection completion rate
大体时间：Baseline through 24 months
|
Baseline through 24 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jianxing、The First Affiliated Hospital of Guangzhou Medical University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2028年12月1日
研究完成 (估计的)
2028年12月1日
研究注册日期
首次提交
2026年6月2日
首先提交符合 QC 标准的
2026年6月12日
首次发布 (实际的)
2026年6月15日
研究记录更新
最后更新发布 (实际的)
2026年6月15日
上次提交的符合 QC 标准的更新
2026年6月12日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.