NCT04965259

Early Detection of Hepatocellular Carcinoma in a High-risk Prospective Cohort (ELEGANCE)

Active, enrolled Last updated 2 July 2025

What this trial tests

trial in Liver Diseases in 2,002 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 April 2021

Primary endpoint
11 March 2025

21 December 2026

Quick facts

Lead sponsor	National Cancer Centre, Singapore
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	2,002
Start date	15 April 2021
Primary completion	11 March 2025
Estimated completion	21 December 2026
Sites	14 locations across Singapore

Conditions studied

• Liver Diseases — all drugs for Liver Diseases →

Sponsor

National Cancer Centre, Singapore

Who can join

Adults 40 to 90, any sex, with Liver Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hepatocellular carcinoma (HCC) is the 7th most common cause of cancer death globally but only 20% are diagnosed in its early stages where cure is possible. Current standard-of-care surveillance of patients at high risk of developing HCC with 6-monthly serum alpha-fetoprotein (AFP) and ultrasound imaging (US) has a sensitivity of approximately 63% for detecting early HCC. There is an urgent need for a more efficacious and convenient modality of surveillance of high-risk patients to diagnose HCC at an early stage.

This prospective study aims to address this unmet clinical need by validating a panel of circulating miRNA biomarkers to develop an in-vitro diagnostic (IVD) kit for the detection of early HCC in a cohort of high-risk patients.

Additionally, this study also aims to develop a multi-parametric MRI-based AI algorithm to quantify individual risks of developing HCC and to predict the progression of chronic liver disease in this cohort to enable targeted surveillance. Lastly, by identifying changes in the microbiome and metabolites as HCC develops in this cohort enables the establishment of actionable biomarkers that can prevent and predict the development of HCC.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Risk stratification and early detection biomarkers for precision HCC screening.
   Lee YT, Fujiwara N, Yang JD, Hoshida Y. · · 2023 · cited 90× · PMID 36082510 · DOI 10.1002/hep.32779
2. Enhancing clinical potential of liquid biopsy through a multi-omic approach: A systematic review.
   Di Sario G, Rossella V, Famulari ES, Maurizio A, et al · · 2023 · cited 42× · PMID 37077538 · DOI 10.3389/fgene.2023.1152470
3. An Update in Epigenetics in Metabolic-Associated Fatty Liver Disease.
   Rodríguez-Sanabria JS, Escutia-Gutiérrez R, Rosas-Campos R, Armendáriz-Borunda JS, et al · · 2021 · cited 24× · PMID 35087844 · DOI 10.3389/fmed.2021.770504
4. Gut microbiota-mediated gut-liver axis: a breakthrough point for understanding and treating liver cancer.
   Li C, Cai C, Wang C, Chen X, et al · · 2025 · cited 22× · PMID 39659059 · DOI 10.3350/cmh.2024.0857
5. The epigenetic basis of hepatocellular carcinoma - mechanisms and potential directions for biomarkers and therapeutics.
   Lin HY, Jeon AJ, Chen K, Lee CJM, et al · · 2025 · cited 16× · PMID 40057667 · DOI 10.1038/s41416-025-02969-8
6. Hepatocellular carcinoma, hepatitis C virus infection and miRNA involvement: Perspectives for new therapeutic approaches.
   Badami E, Busà R, Douradinha B, Russelli G, et al · · 2022 · cited 16× · PMID 35979260 · DOI 10.3748/wjg.v28.i22.2417
7. From Non-Alcoholic Fatty Liver Disease to Liver Cancer: Microbiota and Inflammation as Key Players.
   Rodríguez-Lara A, Rueda-Robles A, Sáez-Lara MJ, Plaza-Diaz J, et al · · 2023 · cited 15× · PMID 37513787 · DOI 10.3390/pathogens12070940
8. miRNAs in HCC, pathogenesis, and targets.
   Song G, Yu X, Shi H, Sun B, et al · · 2024 · cited 8× · PMID 39626210 · DOI 10.1097/hep.0000000000001177