Single-Center CyTOF and Viral Imprinting Study 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

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.

Disqualifiers

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.

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

Retrospective

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 from baseline in percentage of peripheral blood CD8+ CD57+ T cells measured by CyTOF

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.

Time frame
Baseline and routine follow-up blood collections through 24 months

Secondary outcomes

1

Number and percentage of participants with pulmonary nodule evolution events assessed by routine chest CT

Time frame
Baseline through 24 months
2

CMV IgG serostatus measured by institutional immunoassay

Time frame
Baseline
3

Research blood collection completion rate

Time frame
Baseline through 24 months
4

Blood draw-related adverse events

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: