Clinical trial · Observational
Project for Multi-Omics-Based Early Detection of Hepatocellular Carcinoma (PROMETHEA Study)
NCT07265271CI-TRIAL-00116449CENTINELrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hepatocellular carcinoma (HCC) is often diagnosed at an advanced stage, and early detection is critical for improving patient outcomes. Despite this, reliable non-invasive biomarkers for early-stage HCC are limited. This study seeks to develop a multi-omics-based liquid biopsy assay, especially focusing on ncRNAs (e.g. tsRNA, miRNA, circRNA, lncRNA, etc.) for accurate detection of early-stage HCC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rt-qPCR | Diagnostic Test | — | UNRESOLVED |
| Small RNA sequence | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- HCC (Discovery, Small RNA-seq)
- description
- Patient diagnosed with hepatocellular carcinoma, including cases with HBV-, HCV-, and NBNC-related etiologies. Blood or other biospecimens will be collected for multi-omics profiling
- interventionNames
- Diagnostic Test: Small RNA sequence
- Diagnostic Test: Rt-qPCR
- label
- Chronic Liver Disease (CLD) cohort
- description
- Patients with chronic liver disease, including liver cirrhosis and chronic hepatitis, without evidence of hepatocellular carcinoma. Blood or other biospecimens will be collected for multi-omics profiling.
- interventionNames
- Diagnostic Test: Small RNA sequence
- Diagnostic Test: Rt-qPCR
- label
- Healthy Controls
- description
- Healthy individuals without known liver disease or malignancy who will provide blood or other biospecimens as normal controls for biomarker evaluation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults aged 18 to 100 years. * A histologically confirmed diagnosis of hepatocellular carcinoma. * A clinically diagnosed as chronic liver disease, including chronic hepatitis or liver cirrhosis, without evidence of hepatocellular carcinoma. * Healthy volunteers without known liver disease or malignancy. * Received standard diagnostic and staging procedures as per local guidelines * Availability of blood or other biospecimens. * Ability to provide written informed consent. Exclusion Criteria: * Lack of or inability to provide informed consent * History of other active malignancies within the past 5 years * Previous liver transplantation * Severe systemic infection or inflammatory disease at the time of enrollment * Inadequate sample quality or quantity
References
Publications (11)
- BACKGROUNDShao Y, Yu X, Zhou W, Yan J, Dong H, Ye G. Biological roles and potential clinical value of tRNA-derived small RNAs in gastrointestinal malignancies. Ann Med. 2025 Dec;57(1):2566866. doi: 10.1080/07853890.2025.2566866. Epub 2025 Oct 9. PMID 41069160
- BACKGROUNDMao M, Chen W, Huang X, Ye D. Role of tRNA-derived small RNAs(tsRNAs) in the diagnosis and treatment of malignant tumours. Cell Commun Signal. 2023 Jul 21;21(1):178. doi: 10.1186/s12964-023-01199-w. PMID 37480078
- BACKGROUNDLee S, Kim J, Valdmanis PN, Kim HK. Emerging roles of tRNA-derived small RNAs in cancer biology. Exp Mol Med. 2023 Jul;55(7):1293-1304. doi: 10.1038/s12276-023-01038-5. Epub 2023 Jul 10. PMID 37430089
- BACKGROUNDZhou M, He X, Zhang J, Mei C, Zhong B, Ou C. tRNA-derived small RNAs in human cancers: roles, mechanisms, and clinical application. Mol Cancer. 2024 Apr 15;23(1):76. doi: 10.1186/s12943-024-01992-2. PMID 38622694
- BACKGROUNDYuan J, Gu WC, Xu TX, Shen XJ, Li X, Shen L, Zhang Y, Ju SQ. 5'-transfer RNA halve-lysine-CTT as a promising biomarker for early detection of hepatocellular carcinoma. World J Gastrointest Oncol. 2025 Nov 15;17(11):111142. doi: 10.4251/wjgo.v17.i11.111142. PMID 41281472
- BACKGROUNDSauzay C, Petit A, Bourgeois AM, Barbare JC, Chauffert B, Galmiche A, Houessinon A. Alpha-foetoprotein (AFP): A multi-purpose marker in hepatocellular carcinoma. Clin Chim Acta. 2016 Dec 1;463:39-44. doi: 10.1016/j.cca.2016.10.006. Epub 2016 Oct 11. PMID 27732875
- BACKGROUNDLlovet JM, Kelley RK, Villanueva A, Singal AG, Pikarsky E, Roayaie S, Lencioni R, Koike K, Zucman-Rossi J, Finn RS. Hepatocellular carcinoma. Nat Rev Dis Primers. 2021 Jan 21;7(1):6. doi: 10.1038/s41572-020-00240-3. PMID 33479224