Circulating Immune Markers for Prognostic Evaluation in Postoperative Lung Cancer Patients

NCT ID: NCT07242482

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-17
• Study Completion Date: 2029-12-31

Brief Summary

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.

Detailed Description

Non-small cell lung cancer (NSCLC) remains the leading cause of cancer-related mortality worldwide, with surgical resection serving as the curative approach for early to intermediate stages. However, postoperative recurrence rates are high in stages IB (with high-risk features such as tumor >4 cm, poor differentiation, visceral pleural invasion, vascular invasion, or wedge resection) to IIIB, necessitating improved prognostic tools beyond TNM staging to optimize adjuvant therapies like chemotherapy or immunotherapy.

This study investigates peripheral blood immune markers as non-invasive prognostic indicators. Antigen-specific effector T cells (ETASTs) are identified via multiparametric flow cytometry, co-expressing CD137 (a T-cell activation marker) and IFN-γ (an effector cytokine) following ex vivo stimulation with tumor-associated antigens. The effector T cell to regulatory T cell ratio (Teff/Treg) reflects systemic immune homeostasis, with imbalances promoting tumor immune evasion.

Blood samples (approximately 10 mL) are collected preoperatively via venipuncture and processed within 4 hours. Peripheral blood mononuclear cells (PBMCs) are isolated using Ficoll density gradient centrifugation. For ETAST detection, PBMCs undergo stimulation with a peptide pool of common NSCLC antigens (e.g., NY-ESO-1, MAGE-A3) for 6 hours in the presence of brefeldin A, followed by intracellular staining and analysis on a BD FACSCanto II flow cytometer. Teff cells are defined as CD4+ or CD8+ T cells expressing IFN-γ, TNF-α, or IL-2; Treg cells as CD4+CD25+FoxP3+. Data acquisition targets at least 100,000 events per sample, with analysis using FlowJo software.

Follow-up includes clinical assessments every 3 months for the first 2 years, then every 6 months up to 3 years, monitoring recurrence via CT scans, PET-CT if indicated, and survival endpoints. Exploratory analyses may incorporate next-generation sequencing for driver mutations (e.g., EGFR, ALK) from tumor tissue to correlate with immune profiles.

Ethical considerations prioritize participant safety, with all procedures approved by the institutional review board. Data are de-identified and stored securely, complying with GCP standards.

Conditions

Lung Cancer (Diagnosis); Biomarkers / Blood

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Preoperative Peripheral Blood Immune Marker Analysis.

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.
• Voluntarily signs the informed consent form.

Exclusion Criteria

• 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.
• Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhao Jun

OTHER

Sponsor Role: lead

Responsible Party

Zhao Jun

Thoracic Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Soochow university, Suzhou, Jiangsu 215000

Suzhou, Jiangsu, China

Countries

China

Central Contacts

Mi Liu

Role: CONTACT

mi.liu831116@icoud.com

86-0512-67972216

Jun Zhao

Role: CONTACT

zhaojia0327@126.com

86-0512-67972216

Facility Contacts

Jiashan Zhu

Role: primary

zjs18652808112@163.com

86+18652808112

Other Identifiers

2025979

Identifier Type: -

Identifier Source: org_study_id