RecruitingNCT07070011

Small Extracellular Vesicle miRNAs as Predictive Biomarkers for Immunochemotherapy Efficacy in Extensive-stage Small Cell Lung Cancer

Sponsor

Shanghai Chest Hospital of Shanghai Jiao Tong University

Enrollment

38 participants

Start Date

Jan 3, 2023

Study Type

OBSERVATIONAL

Conditions

Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Summary

This study aims to investigate the clinical value of small extracellular vesicle (sEV) miRNAs as predictive biomarkers for immunochemotherapy efficacy in extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC represents a highly aggressive neuroendocrine malignancy, where the current standard first-line treatment combining immune checkpoint inhibitors with chemotherapy lacks predictive biomarkers for individualized therapeutic strategies. A prospective observational cohort will be established at Shanghai Chest Hospital, enrolling treatment-naïve ES-SCLC patients. Distinct miRNA signatures differentiating responders from non-responders will be identified through pretreatment serum sEV miRNA sequencing and differential expression analysis. These findings may provide novel liquid biopsy biomarkers to guide personalized treatment strategies and optimize clinical decision-making in ES-SCLC management.

Eligibility

Min Age: 45 YearsMax Age: 80 Years

Inclusion Criteria5

Requirements for patients enrolled in the project:
The pathological diagnosis of the patient is ESSCLC;
ECOG score 0 or 1；
The patient is receiving immunotherapy combined with chemotherapy for the first time and has no history of chemotherapy treatment;
Patients with complete clinical sample information who meet the inclusion requirements

Exclusion Criteria4

Patients whose pathological diagnosis does not meet the requirements;
Patients whose ECOG staging does not meet the requirements;
Patients with a history of chemotherapy, immunotherapy, or immunotherapy combined with chemotherapy;
Patients with incomplete clinical sample information and follow-up information;