Multiple Pulmonary NodulesNCT07647484
Peripheral Blood CyTOF and Viral Imprinting in Postoperative Multiple Pulmonary Nodules
An observational study of Multiple Pulmonary Nodules, run by The First Affiliated Hospital of Guangzhou Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Pulmonary Nodules
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Dec 2028
- How long will I take part?
- 200 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Conditions
- Multiple Pulmonary Nodules
- Keywords
- CyTOF
- Medical subject headings
- Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and routine follow-up visits through 24 months
Secondary outcomes (5)
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.
Measured: Baseline through 24 months
Blood draw-related adverse events
Measured: At each research blood collection visit from baseline through 24 months
Percentage of participants with positive CMV IgG measured by institutional immunoassay
Measured: Baseline
CyTOF assay completion rate
Measured: Baseline through 24 months
Research blood collection completion rate
Measured: Baseline through 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Pulmonary NodulesStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 200 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Jianxing, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647484
- Sponsor's protocol ID
- GMUFAH-CyTOF-VAI-MC01
- Status last verified
- May 2026
- First submitted
- 2 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Cohort Study of Peripheral Blood CyTOF Immune Phenotyping and Viral Imprinting in Patients With Postoperative Multiple Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT07647484
- Acronym / sponsor ID
- GMUFAH-CyTOF-VAI-MC01
- Conditions
- Multiple Pulmonary Nodules
- Keywords
- CyTOF
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 200 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in percentage from baseline in peripheral blood CyTOF-defined immune phenotype parameters
Time frame: 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.
5 secondary outcomes
Percentage of participants with pulmonary nodule evolution events assessed by routine chest CT
Time frame: Baseline through 24 months
Blood draw-related adverse events
Time frame: At each research blood collection visit from baseline through 24 months
Percentage of participants with positive CMV IgG measured by institutional immunoassay
Time frame: Baseline
CyTOF assay completion rate
Time frame: Baseline through 24 months
Research blood collection completion rate
Time frame: Baseline through 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianxing principal investigator
The First Affiliated Hospital of Guangzhou Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Pulmonary Nodules, run by The First Affiliated Hospital of Guangzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianxing He (020-83062810, jianxinghe@gzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percentage from baseline in peripheral blood CyTOF-defined immune phenotype parameters (time frame: Baseline and routine follow-up visits through 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.