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Circulating Immune Markers for Prognostic Evaluation in Postoperative Lung Cancer Patients

ConditionsLung Cancer (Diagnosis)Biomarkers / Blood
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorZhao Jun

About this trial

Investigating the Clinical Value of Tumor Antigen-Specific T Cells and Immune Cell Balance in Peripheral Blood of Non-Small Cell Lung Cancer Patients for Prognostic Evaluation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 80 years.

Diagnosed with primary non-small cell lung cancer (NSCLC) and scheduled to undergo curative lung resection at the Department of Thoracic Surgery of our institution.

Postoperative pathological stage is IB (with tumor size >4cm or high-risk factors: poor differentiation, vascular invasion, visceral pleural invasion, sub-lobar resection, etc.), IIA, IIB, or IIIB (according to the AJCC 8th edition).

ECOG performance status of 0 or 1.

Disqualifiers

Received any neoadjuvant therapy prior to surgery.

History of other active malignancies.

Diagnosed with severe autoimmune diseases, active infections, or immunodeficiency disorders.

Presence of severe cardiac, hepatic, or renal dysfunction.

Trial population

This is a single-center, prospective, observational cohort study. The study population consists of adult patients (18-80 years) with primary non-small cell lung cancer who are scheduled for curative resection at the Thoracic Surgery Department. Eligible patients must have a postoperative pathological stage of IB (with high-risk features), IIA, IIB, or IIIB (AJCC 8th ed.), an ECOG status of 0-1, and provide informed consent. Key exclusions include prior neoadjuvant therapy, other active cancers, and significant comorbidities. A total of 200 participants are planned to be enrolled.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Preoperative Peripheral Blood Immune Marker Analysis.

    Diagnostic test

    Preoperative collection of approximately 5 mL peripheral blood via venipuncture, followed by isolation of peripheral blood mononuclear cells (PBMCs) using Ficoll density gradient centrifugation. PBMCs are analyzed via multiparametric flow cytometry on a BD FACSCanto II system to quantify antigen-specific effector T cells (ETASTs, co-expressing CD137 and IFN-γ after ex vivo stimulation with NSCLC antigen peptide pools like NY-ESO-1 and MAGE-A3) and the effector T cell to regulatory T cell ratio (Teff/Treg, with Teff as CD4+/CD8+ expressing IFN-γ/TNF-α/IL-2 and Treg as CD4+CD25+FoxP3+). Analysis uses FlowJo software, targeting 100,000 events per sample. This non-invasive prognostic assessment is distinct from routine clinical blood tests by its focus on tumor-specific immune activation and balance, without therapeutic intent or alteration of standard care.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Recurrence-Free Survival

The time from the date of surgery to the first occurrence of disease recurrence, metastasis, or death from any cause.

Time frame
3 years postoperatively

Secondary outcomes

1

Overall Survival

The time from the date of surgery to death from any cause.

Time frame
3 years postoperatively
2

Correlation between immune markers and clinicopathological features

To analyze the associations between preoperative levels of ETASTs, Teff/Treg ratio, and clinicopathological characteristics such as TNM stage, pathological type, and driver gene mutation status.

Time frame
Baseline (preoperative)
3

Immunological prognostic scoring model (Nomogram)

To develop a nomogram model integrating significant immune markers (e.g., ETASTs, Teff/Treg ratio) and clinical variables (e.g., TNM stage) for predicting recurrence-free survival. The model will be internally validated using the Bootstrap method, and its discrimination (C-index) and calibration will be assessed.

Time frame
3 years postoperatively

Other outcomes

Sponsors and contacts

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

Zhao Jun

Lead sponsor

The First Affiliated Hospital of Soochow University

Sponsor institution

Source ClinicalTrials.gov

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