Noninvasive blood miRNA test to screen for multiple gastrointestinal cancers.
A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer
This project will test whether a blood-based microRNA panel can detect several types of gastrointestinal cancer in adults using stored blood samples.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT07224750 on ClinicalTrials.gov |
What this trial studies
This retrospective international, multi-center analysis will use archived peripheral blood samples from adults with major gastrointestinal cancers (including HCC, CCA, PDAC, ESCC, GC, and CRC) and non-malignant controls. Small RNA sequencing will generate circulating miRNA expression profiles followed by preprocessing, normalization, and batch-effect correction to harmonize data across cohorts and platforms. Machine-learning feature selection and classifier development (for example LASSO, mRMR, SVM, Random Forest, XGBoost) will be used to derive a compact miRNA panel that distinguishes cancer from non-cancer and to explore tumor-origin signals. The resulting signature will undergo multi-center training and validation to test robustness across geographic regions, sequencing platforms, and clinical demographics.
Who should consider this trial
Good fit: Adults (≥18) with confirmed diagnoses of major gastrointestinal cancers (HCC, cholangiocarcinoma, PDAC, ESCC, gastric cancer, colorectal cancer) or non-cancer controls who have available, high-quality archived peripheral blood samples and de-identified clinical data are ideal candidates.
Not a fit: People without available or sufficient-quality archived blood samples, those with other active malignancies, or patients needing immediate diagnostic results are unlikely to benefit from participation in this retrospective analysis.
Why it matters
Potential benefit: If successful, this could lead to a simple blood test that detects multiple gastrointestinal cancers earlier, potentially expanding treatment options and improving outcomes.
How similar studies have performed: Prior smaller studies have shown circulating miRNAs can distinguish some cancers, but large multi-center, multi-cancer miRNA panels with rigorous external validation remain limited and unproven at scale.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Duarte, California
- City of Hope Nat Medical Ctr — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Ajay Goel, PhD — City of Hope Medical Center
- Study coordinator: Junyong Weng, PhD
- Email: juweng@coh.org
- Phone: 06263151444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.