A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer

Gastrointestinal (GI) cancers remain a major global health burden, largely due to the lack of effective and accessible early screening strategies. Current diagnostic approaches-including endoscopy, computed tomography (CT), and magnetic resonance imaging (MRI)-are either invasive, resource-intensive, or insufficiently sensitive for detecting early-stage disease, and are therefore not suitable for population-wide screening or for simultaneously identifying multiple GI tumor types. As a result, many patients are diagnosed at advanced stages, when therapeutic options are limited and prognosis is poor. Circulating microRNAs (miRNAs) offer a promising alternative, as they are stable in peripheral blood and reflect tumor-related molecular alterations. In this study, the investigators aim to develop and validate a robust, noninvasive miRNA-based signature capable of distinguishing GI cancers from non-malignant controls. By integrating multi-cohort datasets and applying machine learning-based feature selection and predictive modeling, the investigators will construct a screening panel optimized for reproducibility, scalability, and early-stage detection. This noninvasive miRNA signature has the potential to support accessible, cost-effective, and clinically practical population-level screening for GI cancers, ultimately facilitating earlier diagnosis and improving outcomes for participants.

NCT Number	NCT07224750
Lead Sponsor	City of Hope Medical Center
Conditions	Hepatocellular Carcinoma (HCC), Cholangiocarcinoma, Pancreatic Ductal Adenocarcinoma (PDAC), Esophageal Squamous Cell Carcinoma (ESCC), Gastric Cancer (GC), Colorectal Cancer Screening
Enrollment	1,000 participants
Start Date	2024-06-21
Primary Completion	2028-06-18 (estimated)
Study Completion	2028-06-18 (estimated)
Updated on ClinicalTrials.gov	2026-07-07