NCT07265271|Recruiting
Project for Multi-Omics-Based Early Detection of Hepatocellular Carcinoma (PROMETHEA Study)
CENTINEL
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CENTINEL
Sponsor study identifier
observational
600
1 country
1
Study Start
January 15, 2025
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.
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.
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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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 15, 2025
Actual (reported)November 24, 2025
Actual (reported)December 4, 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 performance of the integrated multi-omics signature for hepatocellular carcinoma detection
To evaluate the diagnostic accuracy of the model for distinguishing patients with hepatocellular carcinoma from chronic liver disease and healthy controls, as assessed by the area under the operating characteristic curve (AUC), sensitivity, and specificity.
At the baseline
Validation of the diagnostic model in independent cohorts
At the baseline
Identification of etiology-associated omics profiles in hepatocellular carcinoma
At the baseline
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
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.
Healthy individuals without known liver disease or malignancy who will provide blood or other biospecimens as normal controls for biomarker evaluation.
Comprehensive small RNA sequencing of serum or plasma-derived cf-tsRNAs to identify candidate biomarkers distinguishing HCC from NDC.
Individuals who were diagnosed with hepatocellular carcinoma. Individuals who were diagnosed with chronic liver disease Healthy donors
City of Hope Medical Center
Duarte, California, 91016, United States
Shao 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.
Mao 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.
Plasma or serum
First Submitted
November 24, 2025
First Posted
December 4, 2025
Study Start
January 15, 2025
Actual (reported)Primary Completion
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Adaptive Dosing of Immune Checkpoint Inhibitors for Hepatocellular Carcinoma
Construction of integrated cf- tsmiRNAs diagnostic classifier using machine learning
PCR-based validation of the tsRNA panel
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Lee 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.
Zhou 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.
Yuan 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.
Sauzay 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.
Llovet 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.
Xing H, Zheng YJ, Han J, Zhang H, Li ZL, Lau WY, Shen F, Yang T. Protein induced by vitamin K absence or antagonist-II versus alpha-fetoprotein in the diagnosis of hepatocellular carcinoma: A systematic review with meta-analysis. Hepatobiliary Pancreat Dis Int. 2018 Dec;17(6):487-495. doi: 10.1016/j.hbpd.2018.09.009. Epub 2018 Sep 15.
Choi JY, Jung SW, Kim HY, Kim M, Kim Y, Kim DG, Oh EJ. Diagnostic value of AFP-L3 and PIVKA-II in hepatocellular carcinoma according to total-AFP. World J Gastroenterol. 2013 Jan 21;19(3):339-46. doi: 10.3748/wjg.v19.i3.339.
Xu J, Chen B, Qi J, Wu J, Feng W, Jin K, Bao H, Chen L, Wang F. Evaluation of serum hsa_tsr014055 as a potential biomarker for diagnosis and prognosis of hepatocellular carcinoma. Ann Med. 2025 Dec;57(1):2528978. doi: 10.1080/07853890.2025.2528978. Epub 2025 Jul 6.
Jin K, Wu J, Yang J, Chen B, Xu J, Bao H, Zong W, Xie C, Chen L, Wang F. Identification of serum tsRNA-Thr-5-0015 and combined with AFP and PIVKA-II as novel biomarkers for hepatocellular carcinoma. Sci Rep. 2024 Nov 21;14(1):28834. doi: 10.1038/s41598-024-80592-y.
Study Completion
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 1, 2026
Record last verified: 2026-06
Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data.
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