Circulating Immune Markers for Prognostic Evaluation in Postoperative Lung Cancer Patients

NCT07242482 | Not Yet Recruiting

• 1 other identifier: 2025979
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer (Diagnosis); Biomarkers / Blood

Keywords

Peripheral Blood; Tumor antigen specific T cells; Teff/Treg ratio; Prognostic Evaluation

Outcome Measures

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.

  3 years postoperatively

Secondary Outcomes (3)

• Overall Survival

  3 years postoperatively

• Correlation between immune markers and clinicopathological features

  Baseline (preoperative)

• Immunological prognostic scoring model (Nomogram)

  3 years postoperatively

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhao Jun: lead

Study Sites (1)

Soochow university, Suzhou, Jiangsu 215000

Suzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mi Liu

CONTACT

86-0512-67972216; mi.liu831116@icoud.com

Jun Zhao

CONTACT

86-0512-67972216; zhaojia0327@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Thoracic Surgery

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

CN (1)