A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer

What this Trial Is About

Gastrointestinal (GI) cancers, including hepatocellular carcinoma, cholangiocarcinoma, pancreatic ductal adenocarcinoma, esophageal squamous cell carcinoma, gastric cancer, and colorectal cancer, continue to be a significant global health concern. This research aims to develop a noninvasive screening test using circulating microRNAs (miRNAs) to better detect these cancers early. Current methods like endoscopy and imaging are invasive or less sensitive, making early diagnosis difficult and limiting treatment options. The study seeks to create a cost-effective and practical miRNA signature to improve early detection and outcomes for patients. This study uses a retrospective international cohort of blood samples from patients with various GI cancers and non-cancer controls, including healthy volunteers and those with benign conditions. Small RNA sequencing will identify miRNA profiles, and advanced machine learning methods will be applied to develop a miRNA panel that can distinguish cancer from non-cancer cases and differentiate among cancer types. The study includes discovery, modeling, and validation phases across multiple centers and diverse populations to ensure the panel's accuracy and reliability. Participants contribute by providing blood samples collected before treatment, and researchers will analyze these samples along with clinical and demographic data. The study will assess the diagnostic accuracy of the miRNA panel at baseline, focusing on its ability to detect early-stage cancers and distinguish cancer subtypes. This observational study involves no treatment interventions, and participation mainly consists of data and sample analysis. The study is expected to continue until June 2026, with ongoing monitoring of the miRNA panel's performance.

A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer