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

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

Plain Language Summary

Simplified for easier understanding

This study investigates whether tiny particles in the blood called microRNAs (carried in small cell fragments) can predict how well patients with extensive-stage small cell lung cancer will respond to immunotherapy combined with chemotherapy. The goal is to find a simple blood test that could tell doctors early on whether the treatment is working. **You may be eligible if...** - You have been diagnosed with extensive-stage small cell lung cancer (confirmed by pathology) - You have a good performance status (able to carry out normal activities with minimal symptoms) - You are receiving immunotherapy plus chemotherapy for the first time - You have not had prior chemotherapy **You may NOT be eligible if...** - You have already received chemotherapy - Your cancer is a different type or stage of lung cancer - You have poor overall health status Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTEC/EP + ICIs

Collect blood samples from patients with small cell lung cancer before receiving immunotherapy combined with chemotherapy.


Locations(1)

Shanghai Chest Hospital

Shanghai, China

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NCT07070011


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