A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer

Recruiting now

Conditions studied: Hepatocellular Carcinoma (HCC), Cholangiocarcinoma, Pancreatic Ductal Adenocarcinoma (PDAC), Esophageal Squamous Cell Carcinoma (ESCC), Gastric Cancer (GC), Colorectal Cancer Screening

In brief

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.

Key facts

Study ID

NCT07224750

Run by

City of Hope Medical Center

People needed

1000

Starts

2024-06-21

Expected to finish

2028-06-18

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults aged 18 years or older at the time of blood sample collection.
• Patients with a confirmed diagnosis of one of the following gastrointestinal cancers: Hepatocellular carcinoma (HCC), Cholangiocarcinoma (CCA), Pancreatic ductal adenocarcinoma (PDAC), Esophageal squamous cell carcinoma (ESCC), Gastric cancer (GC), Colorectal cancer (CRC), Non-cancer control participants, including healthy volunteers or patients with benign gastrointestinal conditions.
• Availability of retrospective blood samples collected according to institutional protocols.
• Willingness to allow use of de-identified clinical and demographic data for research purposes.

You may not qualify if…

• other active malignancies; insufficient sample quality/volume; recent chemotherapy/radiotherapy/surgery; any condition preventing reliable participation.

Where it is running

• City of Hope Nat Medical Ctr — Duarte, California, United States (enrolling)

Full record on ClinicalTrials.gov

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