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

Официальное название

A Single-Center Prospective Cohort Study of Peripheral Blood CyTOF Immune Phenotyping and Viral Imprinting in Patients With Postoperative Multiple Pulmonary Nodules

Обзор

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.

Первичные конечные точки

• Change from baseline in percentage of peripheral blood CD8+ CD57+ T cells measured by CyTOF [Срок оценки: Baseline and routine follow-up blood collections through 24 months]

Вторичные конечные точки (8)

• Number and percentage of participants with pulmonary nodule evolution events assessed by routine chest CT [Срок оценки: Baseline through 24 months]
• CMV IgG serostatus measured by institutional immunoassay [Срок оценки: Baseline]
• Research blood collection completion rate [Срок оценки: Baseline through 24 months]
• Blood draw-related adverse events [Срок оценки: At each research blood collection visit from baseline through 24 months]
• EBV VCA-IgG serostatus measured by institutional immunoassay [Срок оценки: Baseline]
• EBV EBNA-IgG serostatus measured by institutional immunoassay [Срок оценки: Baseline]
• HPV L1 antibody serostatus measured by institutional immunoassay [Срок оценки: Baseline]
• CyTOF assay completion rate [Срок оценки: Baseline through 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07647055 · ES-2025-266-288888

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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