RecruitingNCT07266363

Integrated Cf-miRNA and Exosomal miRNA Signature for Early Detection of Esophageal Squamous Cell Carcinoma

SYNERGY Study: Early Detection Through Integrated Evaluation of Cell-Free and Exosomal microRNAs for Biomarker-Guided Screening of Esophageal Squamous Cell Carcinoma

Sponsor

City of Hope Medical Center

Enrollment

600 participants

Start Date

Jan 15, 2025

Study Type

OBSERVATIONAL

Conditions

ESCC

Summary

Esophageal squamous cell carcinoma (ESCC) remains a highly lethal cancer worldwide, largely due to late diagnosis. Current screening methods such as upper endoscopy are invasive, operator-dependent, and limited in their ability to detect early-stage lesions. To address this clinical need, the SYNERGY study seeks to develop a non-invasive, blood-based biomarker assay that integrates cell-free microRNAs (cf-miRNAs) and exosomal microRNAs (exo-miRNAs) to detect ESCC at an early and potentially curable stage. This multicenter translational study includes discovery, training, and validation phases using preoperative plasma or serum samples. By combining the tumor specificity of exosomal miRNAs with the systemic sensitivity of cf-miRNAs, SYNERGY aims to construct a robust diagnostic model with high sensitivity and specificity for early ESCC detection.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is trying to develop a blood test to detect esophageal squamous cell carcinoma (a type of cancer of the food pipe) at an early stage, by analyzing tiny RNA molecules found in the blood. Researchers are comparing samples from people with and without the cancer. This is not a treatment study. **You may be eligible if...** - You are between 18 and 90 years old - You have been diagnosed with esophageal squamous cell carcinoma, confirmed by tissue biopsy - You have not yet received any cancer treatment (blood sample must be taken before treatment begins) - For the control (comparison) group: you do not have cancer **You may NOT be eligible if...** - You are unwilling or unable to provide consent - Your blood sample has insufficient volume or quality for RNA analysis - You have had a different cancer diagnosis within the past 5 years (some minor localized cancers may be exceptions) - You have an active inflammatory condition that could affect the blood results 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.

Interested in this trial?

Get notified about updates and connect with the research team.