A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer (MiGIC)

November 24, 2025 updated by: City of Hope Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study will establish a comprehensive, retrospective, international multi-center cohort consisting of peripheral blood samples from participants with major gastrointestinal cancers-including hepatocellular carcinoma (HCC), cholangiocarcinoma (CCA), pancreatic ductal adenocarcinoma (PDAC), esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), and colorectal cancer (CRC)-as well as non-malignant controls. Small RNA sequencing will be performed to generate high-resolution circulating miRNA expression profiles.

During the discovery phase, the investigators will conduct rigorous preprocessing, normalization, batch effect correction, and differential expression analyses to identify circulating miRNAs associated with malignant transformation across GI cancer types. Machine learning-based feature selection (e.g., LASSO, mRMR, ensemble methods) and classifier development (e.g., SVM, Random Forest, XGBoost) will then be used to derive a minimal yet robust miRNA panel capable of optimally distinguishing cancer from non-cancer.

During the modeling and evaluation phase, the identified miRNA signature will undergo multi-center training and validation across international cohorts to ensure robustness across geographic regions, sequencing platforms, and clinical demographics. Beyond binary classification, the investigators will assess the panel's ability to discriminate among specific GI cancer subtypes, thereby supporting differential diagnosis and tumor-origin inference. Model performance will be evaluated using AUROC, sensitivity at clinically meaningful specificity thresholds, early-stage detection capability, and calibration in independent validation cohorts.

Through this sequential discovery → modeling → multi-center validation framework, the investigators aim to develop a noninvasive circulating miRNA panel that (1) accurately distinguishes cancer from non-cancer individuals and (2) differentiates among multiple gastrointestinal cancer types, thereby providing a clinically scalable solution for early cancer detection and population-level screening.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Junyong Weng, PhD
  • Phone Number: 06263151444
  • Email: juweng@coh.org

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Nat Medical Ctr
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adult participants (≥18 years) from international multi-center cohorts, including patients with GI cancers (HCC, CCA, PDAC, ESCC, GC, CRC) and non-cancer controls. Blood samples and de-identified clinical data are available for discovery, training, and validation of a circulating miRNA biomarker panel.

Description

Inclusion Criteria:

  1. Adults aged 18 years or older at the time of blood sample collection.
  2. 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.
  3. Availability of retrospective blood samples collected according to institutional protocols.
  4. Willingness to allow use of de-identified clinical and demographic data for research purposes.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Hepatocellular Carcinoma cohort
Patients diagnosed with hepatocellular carcinoma (HCC) confirmed by clinical, imaging, and/or histopathological criteria. Blood samples collected retrospectively from multiple international centers.
Cholangiocarcinoma cohort
Patients diagnosed with cholangiocarcinoma (CCA), including intrahepatic and extrahepatic subtypes, confirmed clinically and/or histopathologically. Blood samples collected retrospectively from multiple international centers.
Pancreatic Ductal Adenocarcinoma cohort
Patients diagnosed with pancreatic ductal adenocarcinoma (PDAC), confirmed by standard diagnostic criteria. Samples collected from multiple international centers.
Esophageal Squamous Cell Carcinoma cohort
Patients diagnosed with esophageal squamous cell carcinoma (ESCC). Blood samples collected retrospectively from international collaborating centers.
Gastric Cancer cohort
Patients diagnosed with gastric cancer (GC), confirmed clinically and/or histopathologically. Samples collected from multiple international centers.
Colorectal Cancer cohort
Patients diagnosed with colorectal cancer (CRC), confirmed by standard diagnostic methods. Blood samples collected retrospectively from multiple international centers.
Non-cancer / Healthy control group
Non-cancer individuals, including healthy volunteers and patients with benign gastrointestinal conditions. Blood samples collected from international centers and matched for age and sex where possible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy of miRNA Panel
Time Frame: At baseline (pre-treatment blood sample).
Sensitivity, specificity, and area under the receiver operating characteristic curve (AUROC) for distinguishing GI cancer patients from non-cancer controls.
At baseline (pre-treatment blood sample).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Investigators

  • Principal Investigator: Ajay Goel, PhD, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2024

Primary Completion (Estimated)

June 18, 2026

Study Completion (Estimated)

June 18, 2026

Study Registration Dates

First Submitted

November 3, 2025

First Submitted That Met QC Criteria

November 3, 2025

First Posted (Estimated)

November 5, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23228/MiGIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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