Development and Validation of a Noninvasive Blood Test Using MicroRNA to Detect Multiple Gastrointestinal Cancers Early

What this Trial Is About

Gastrointestinal cancers cause significant health challenges worldwide due to the lack of effective and accessible early screening methods. Current diagnostic tools like endoscopy and imaging are invasive or not sensitive enough for early detection, leading to diagnoses at advanced stages with limited treatment options. Researchers aim to develop a noninvasive blood test using circulating microRNAs miRNAs that may help detect multiple types of gastrointestinal cancers early, improving possible outcomes. This study collects retrospective blood samples from participants with major gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, pancreatic ductal adenocarcinoma, esophageal squamous cell carcinoma, gastric cancer, and colorectal cancer, as well as from non-cancer controls. Small RNA sequencing will measure circulating miRNA levels. Using machine learning, investigators will identify a minimal panel of miRNAs that can distinguish cancer from non-cancer and differentiate among cancer types across diverse cohorts and geographic regions. Participants blood samples and clinical data will be analyzed to develop and validate this miRNA signature. The study evaluates the accuracy of the miRNA panel for cancer detection using measures like area under the receiver operating characteristic curve and sensitivity. This observational study uses existing samples and data and involves no active treatment. The research aims to create a scalable, cost-effective screening tool to support earlier diagnosis of gastrointestinal cancers.

A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer