ClinicalTrials.gg
Not yet recruitingNCT07647484Updated Jun 15, 2026

Peripheral Blood CyTOF and Viral Imprinting in Postoperative Multiple Pulmonary Nodules

An observational study in Multiple Pulmonary Nodules, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Multiple Pulmonary Nodules

Keywords

  • CyTOF
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In context

Multiple Pulmonary Nodules

99 studies on the registry are indexed under Multiple Pulmonary Nodules; 42 are open to participants now.

This study's planned enrollment of 200 is below the median of 255 across 51 observational studies indexed under Multiple Pulmonary Nodules.

Browse Multiple Pulmonary Nodules studies →

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 167 studies on the registry; 69 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 before research blood sample collection.

Exclusion criteria

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 therapy that may substantially affect peripheral immune status and cannot be adequately recorded or adjusted for in analysis.

Unable to complete 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
200 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

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What researchers measure

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

  5. Research blood collection completion rate

    Time frame: Baseline through 24 months

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Study locations

No study locations are listed for this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Dec 2028, 29 months later.

Of 24 observational studies under Multiple Pulmonary Nodules, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 62. This study's planned 29 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 2, 2026
First posted
Jun 15, 2026
StartEst.
Jul 2026
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2028
Last update
Jun 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07647484
Responsible party
Jianxing He (Principal Investigator, The First Affiliated Hospital of Guangzhou Medical University) — Principal investigator
First posted
Jun 15, 2026
Start date
Jul 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jun 15, 2026

Study contacts

Jianxing He
Contact
jianxinghe@gzhmu.edu.cn
020-83062810
Jianxing
principal investigator · The First Affiliated Hospital of Guangzhou Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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