Peripheral Blood CyTOF and Viral Imprinting in Postoperative Multiple Pulmonary Nodules
12. juni 2026 oppdatert av: Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
200
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jianxing He
- Telefonnummer: 020-83062810
- E-post: jianxinghe@gzhmu.edu.cn
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in percentage from baseline in peripheral blood CyTOF-defined immune phenotype parameters
Tidsramme: 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.
|
Baseline and routine follow-up visits through 24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of participants with pulmonary nodule evolution events assessed by routine chest CT
Tidsramme: Baseline through 24 months
|
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.
|
Baseline through 24 months
|
|
Blood draw-related adverse events
Tidsramme: At each research blood collection visit from baseline through 24 months
|
At each research blood collection visit from baseline through 24 months
|
|
|
Percentage of participants with positive CMV IgG measured by institutional immunoassay
Tidsramme: Baseline
|
Baseline
|
|
|
CyTOF assay completion rate
Tidsramme: Baseline through 24 months
|
Baseline through 24 months
|
|
|
Research blood collection completion rate
Tidsramme: Baseline through 24 months
|
Baseline through 24 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Jianxing, The First Affiliated Hospital of Guangzhou Medical University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
1. desember 2028
Studiet fullført (Antatt)
1. desember 2028
Datoer for studieregistrering
Først innsendt
2. juni 2026
Først innsendt som oppfylte QC-kriteriene
12. juni 2026
Først lagt ut (Faktiske)
15. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GMUFAH-CyTOF-VAI-MC01
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .