A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer
MiGIC
MiGIC
Sponsor study identifier
observational
1,000
1 country
1
Study Start
June 21, 2024
Actual (reported)Primary Completion
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 21, 2024
Actual (reported)November 3, 2025
Actual (reported)November 5, 2025
Actual (reported)June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
At baseline (pre-treatment blood sample).
Patients diagnosed with hepatocellular carcinoma (HCC) confirmed by clinical, imaging, and/or histopathological criteria. Blood samples collected retrospectively from multiple international centers.
Patients diagnosed with cholangiocarcinoma (CCA), including intrahepatic and extrahepatic subtypes, confirmed clinically and/or histopathologically. Blood samples collected retrospectively from multiple international centers.
Patients diagnosed with pancreatic ductal adenocarcinoma (PDAC), confirmed by standard diagnostic criteria. Samples collected from multiple international centers.
Patients diagnosed with esophageal squamous cell carcinoma (ESCC). Blood samples collected retrospectively from international collaborating centers.
Patients diagnosed with gastric cancer (GC), confirmed clinically and/or histopathologically. Samples collected from multiple international centers.
Patients diagnosed with colorectal cancer (CRC), confirmed by standard diagnostic methods. Blood samples collected retrospectively from multiple international centers.
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.
City of Hope Nat Medical Ctr
Duarte, California, 91010, United States
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.
Bray 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.
Ajay Goel, PhD
City of Hope Medical Center
First Submitted
November 3, 2025
First Posted
November 5, 2025
Study Start
June 21, 2024
Actual (reported)Primary Completion
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
To Evaluate the Safety, Tolerability, and Preliminary Efficacy of XH001 Injection as Adjuvant Therapy in Patients With High-risk Recurrent Solid Tumors
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.
Contact the study team to confirm eligibility.
Study Completion
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 7, 2026
Record last verified: 2026-07
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Source: ClinicalTrials.gov.
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