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NCT07224750Recruiting

A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer

Source: ClinicalTrials.gov · Last updated 7 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1000 (estimated)
First submitted
3 Nov 2025
Start date
21 Jun 2024
Primary completion date
18 Jun 2028
Lead sponsor
City of Hope Medical Center
NCT number
NCT07224750

What you commit to

  • Study type: Observational
  • Planned participants: 1000
  • From 21 Jun 2024 to the primary completion date, 18 Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
City of Hope Nat Medical Ctr
Coordinator of this site? Confirm its status
DuarteUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.