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A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study aims to develop and test a blood screening tool for cancers of the digestive system. It looks for patterns in tiny molecules called microRNAs that may help find cancer early. It uses stored blood samples from adults with certain digestive system cancers and adults without cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Were at least 18 years old when the blood sample was taken.
  • Have a confirmed diagnosis of one of these cancers: hepatocellular carcinoma (a liver cancer), cholangiocarcinoma (bile duct cancer), pancreatic ductal adenocarcinoma (a pancreatic cancer), esophageal squamous cell carcinoma (a cancer of the food pipe), stomach cancer, or colon or rectal cancer; OR have no cancer, including healthy volunteers and people with non-cancer digestive conditions.
  • Have a stored blood sample collected under the study site's rules.
  • Agree to let researchers use health and personal background data with identifying details removed.

Who can't join

  • Have another active cancer.
  • The blood sample is too small or is not good enough for testing.
  • Recently had chemotherapy (cancer drugs), radiation treatment, or surgery.
  • Have any condition that prevents reliable participation.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

CA