Recruiting

miRNA Signature

Sponsor:

City of Hope Medical Center

Code:

NCT07224750

Conditions

Hepatocellular Carcinoma (HCC)

Cholangiocarcinoma

Pancreatic Ductal Adenocarcinoma (PDAC)

Esophageal Squamous Cell Carcinoma (ESCC)

Gastric Cancer (GC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Hepatocellular Carcinoma (HCC)

Cholangiocarcinoma

Pancreatic Ductal Adenocarcinoma (PDAC)

Esophageal Squamous Cell Carcinoma (ESCC)

Gastric Cancer (GC)

Study ID

NCT07224750

Start date

Jun 21, 2024

Status verified date

Jul, 2026

Completion date

Jun 18, 2028

Anticipated

Primary completion date

Jun 18, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

City of Hope Nat Medical Ctr

Recruiting

Duarte, California, United States, 91010

Contacts

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Noninvasive screening
  • Circulating miRNA
  • Machine learning
  • Gastrointestinal cancer
  • Blood-based cancer detection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-07-07.