A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07224750
Status
Recruiting
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Conditions

  • Cholangiocarcinoma
  • Colorectal Cancer Screening
  • Esophageal Squamous Cell Carcinoma (ESCC)
  • Gastric Cancer (GC)
  • Hepatocellular Carcinoma (HCC)
  • Pancreatic Ductal Adenocarcinoma (PDAC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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 Dates

Start date
Jun 21, 2024
Status verified
Nov 2025
Primary completion
Jun 18, 2026
Completion
Jun 18, 2026

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: Pancreatic Ductal Adenocarcinoma cohort
    Patients diagnosed with pancreatic ductal adenocarcinoma (PDAC), confirmed by standard diagnostic criteria. Samples collected from multiple international centers.
  • Arm: Esophageal Squamous Cell Carcinoma cohort
    Patients diagnosed with esophageal squamous cell carcinoma (ESCC). Blood samples collected retrospectively from international collaborating centers.
  • Arm: Gastric Cancer cohort
    Patients diagnosed with gastric cancer (GC), confirmed clinically and/or histopathologically. Samples collected from multiple international centers.
  • Arm: Colorectal Cancer cohort
    Patients diagnosed with colorectal cancer (CRC), confirmed by standard diagnostic methods. Blood samples collected retrospectively from multiple international centers.
  • Arm: 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.

Primary Outcome Measure

Diagnostic Accuracy of miRNA Panel [ Time Frame: At baseline (pre-treatment blood sample). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Nat Medical CtrDuarteCalifornia91010
Ajay Goel, PhD
[email protected]
626-359-8111

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By research site
City of Hope Nat Medical Ctr· Duarte, CA

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