Hepatocellular Carcinoma (HCC)MiGICNCT07224750
A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer
An observational study of Hepatocellular Carcinoma (HCC) and Cholangiocarcinoma, run by City of Hope Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Cholangiocarcinoma, Pancreatic Ductal Adenocarcinoma (PDAC)
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2024to 18 Jun 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult participants (≥18 years) from international multi-center cohorts, including patients with GI cancers (HCC, CCA, PDAC, ESCC, GC, CRC) and non-cancer controls. Blood samples and de-identified clinical data are available for discovery, training, and validation of a circulating miRNA biomarker panel.
Who may be able to join
- 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.
Who cannot join
- other active malignancies; insufficient sample quality/volume; recent chemotherapy/radiotherapy/surgery; any condition preventing reliable participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Nat Medical Ctr
Duarte, California, 91010
Ajay Goel, PhD, 6263598111, ajgoel@coh.org
About this study
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.
Read the detailed description
This study will establish a comprehensive, retrospective, international multi-center cohort consisting of peripheral blood samples from participants with major gastrointestinal cancers-including hepatocellular carcinoma (HCC), cholangiocarcinoma (CCA), pancreatic ductal adenocarcinoma (PDAC), esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), and colorectal cancer (CRC)-as well as non-malignant controls. Small RNA sequencing will be performed to generate high-resolution circulating miRNA expression profiles.
During the discovery phase, the investigators will conduct rigorous preprocessing, normalization, batch effect correction, and differential expression analyses to identify circulating miRNAs associated with malignant transformation across GI cancer types. Machine learning-based feature selection (e.g., LASSO, mRMR, ensemble methods) and classifier development (e.g., SVM, Random Forest, XGBoost) will then be used to derive a minimal yet robust miRNA panel capable of optimally distinguishing cancer from non-cancer.
During the modeling and evaluation phase, the identified miRNA signature will undergo multi-center training and validation across international cohorts to ensure robustness across geographic regions, sequencing platforms, and clinical demographics. Beyond binary classification, the investigators will assess the panel's ability to discriminate among specific GI cancer subtypes, thereby supporting differential diagnosis and tumor-origin inference. Model performance will be evaluated using AUROC, sensitivity at clinically meaningful specificity thresholds, early-stage detection capability, and calibration in independent validation cohorts.
Through this sequential discovery → modeling → multi-center validation framework, the investigators aim to develop a noninvasive circulating miRNA panel that (1) accurately distinguishes cancer from non-cancer individuals and (2) differentiates among multiple gastrointestinal cancer types, thereby providing a clinically scalable solution for early cancer detection and population-level screening.
- Conditions
- Hepatocellular Carcinoma (HCC), Cholangiocarcinoma, Pancreatic Ductal Adenocarcinoma (PDAC), Esophageal Squamous Cell Carcinoma (ESCC), Gastric Cancer (GC), Colorectal Cancer Screening
- Keywords
- Noninvasive screening, Circulating miRNA, Machine learning, Gastrointestinal cancer, Blood-based cancer detection
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma, Esophageal Squamous Cell Carcinoma, Stomach Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of miRNA Panel
Sensitivity, specificity, and area under the receiver operating characteristic curve (AUROC) for distinguishing GI cancer patients from non-cancer controls.
Measured: At baseline (pre-treatment blood sample).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start21 Jun 2024
- Primary completion18 Jun 2028 (estimated)
- Study completion18 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ajay Goel, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224750
- Sponsor's protocol ID
- 23228/MiGIC
- Acronym
- MiGIC
- Status last verified
- Jul 2026
- First submitted
- 3 Nov 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goddard KAB, Feuer EJ, Mandelblatt JS, Meza R, Holford TR, Jeon J, Lansdorp-Vogelaar I, Gulati R, Stout NK, Howlader N, Knudsen AB, Miller D, Caswell-Jin JL, Schechter CB, Etzioni R, Trentham-Dietz A, Kurian AW, Plevritis SK, Hampton JM, Stein S, Sun LP, Umar A, Castle PE. Estimation of Cancer Deaths Averted From Prevention, Screening, and Treatment Efforts, 1975-2020. JAMA Oncol. 2025 Feb 1;11(2):162-167. doi: 10.1001/jamaoncol.2024.5381.
PubMed 39636625Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PubMed 38572751