Single-Center CyTOF and Viral Imprinting Study in Postoperative Multiple Pulmonary Nodules
2026年6月9日 更新者：Jianxing He、The First Affiliated Hospital of Guangzhou Medical University
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.
研究概览
地位
尚未招聘
条件
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
|
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 from baseline in percentage of peripheral blood CD8+ CD57+ T cells measured by CyTOF
大体时间：Baseline and routine follow-up blood collections through 24 months
|
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
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
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
|
|
CyTOF assay completion rate
大体时间：Baseline through 24 months
|
Baseline through 24 months
|
|
Research blood collection completion rate
大体时间：Baseline through 24 months
|
Baseline through 24 months
|
|
Number and percentage of participants with pulmonary nodule evolution events assessed by routine chest CT
大体时间：Baseline through 24 months
|
Baseline through 24 months
|
|
CMV IgG serostatus measured by institutional immunoassay
大体时间：Baseline
|
Baseline
|
|
EBV VCA-IgG serostatus measured by institutional immunoassay
大体时间：Baseline
|
Baseline
|
|
EBV EBNA-IgG serostatus measured by institutional immunoassay
大体时间：Baseline
|
Baseline
|
|
HPV L1 antibody serostatus measured by institutional immunoassay
大体时间：Baseline
|
Baseline
|
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。
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9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9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.