Active — Not RecruitingNot Applicable

Prospective Cohort Study of Changes in Circulatory MicroRNA of Resected Hepatocellular Carcinoma

Singapore101 participantsStarted 2021-11-10

Plain-language summary

Hepatocellular carcinoma (HCC) is the 4th most common cause of cancer death globally but only 20% are diagnosed in its early stages where curative treatment can be carried out. 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. In another study (AHCC10 ELEGANCE, NCT04965259), 2,000 patients at risk of developing HCC will be enrolled to develop the 1st miRNA in-vitro diagnostic (IVD) kit for HCC that has higher accuracy and better ease of use compared with the extant combination of AFP and US. This prospective study will act as a positive control to the AHCC10 ELEGANCE Study and aims to address the absence of efficacious modalities of surveillance by validating a panel of circulating miRNA biomarkers signatures with histologically proven HCC. This study will determine progressive changes in the profiles of miRNA signatures pre- and post- surgical resection to identify signatures predictive of recurrence. Additionally, this study also aims to identify changes in key metabolites and microbiome with correlation to changes in choline, bile acid and tryptophan metabolic pathways with changes in the composition and function of gut microbiota to establish actionable biomarkers that can predict HCC recurrence.

Who can participate

Age range21 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The patient is male or female patients, 21 to 90 years of age at the time of signature of the informed consent form. * The patient has clinically AND histologically proven HCC. * The patient has R0 or R1 resection on histology. * The patient has Child-Pugh \<= 7 points without clinical ascites before surgery. * The patient has ECOG performance status 0-1 before surgery. * The patient is scheduled for liver resection within 6 weeks of signing screening informed consent form. * The patient has received no anti-cancer specific treatment for HCC before the surgery (eg. previous liver resection, loco-regional therapy such as RFA, TACE, SIRT, radiotherapy, immunotherapy, chemotherapy or neo-adjuvant chemotherapy), other than the planned surgery. However, patient who has received previous HCC treatment more than 5 years ago is deemed to have a de-novo liver tumour and therefore can be included. * The patient is able to comply with scheduled visits, assessments and other study procedures. * The patient is willing to provide informed consent before enrolment in the study. Exclusion Criteria: * The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and highly likely to have been cured. * The patient has active hepatic encephalopathy at time of enrolment. * The patient has received a m…

What they're measuring

miRNA biomarker signatures diagnostic for HCC or for recurrence prediction.

Timeframe: Baseline and every 6 monthly thereafter, up to 12 months.

Gut microbiome profiling for recurrence prediction.

Timeframe: Baseline and every 6 monthly thereafter, up to 12 months.

Metabolome profiling for recurrence prediction.

Timeframe: Baseline and every 6 monthly thereafter, up to 12 months.

Trial details

NCT IDNCT05148572

SponsorNational Cancer Centre, Singapore

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Hepatocellular Carcinoma trials

Plain-language summary

Who can participate

Age range21 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

miRNA biomarker signatures diagnostic for HCC or for recurrence prediction.

Timeframe: Baseline and every 6 monthly thereafter, up to 12 months.

Gut microbiome profiling for recurrence prediction.

Timeframe: Baseline and every 6 monthly thereafter, up to 12 months.

Metabolome profiling for recurrence prediction.

Timeframe: Baseline and every 6 monthly thereafter, up to 12 months.