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

This is a prospective study involving 100 patients with diagnosis of hepatocellular carcinoma (HCC) confirmed by histology at surgical resection. Eligible patients will receive CT scans at 6 months and 12 months post-surgery to monitor for recurrence. Pre- and post-surgery bio-samples (blood, urine, stool) will also be collected to monitor changes in profiles of miRNA, metabolome and microbiome.

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 major organ allograft.
• The patient is known to be positive for the Human Immunodeficiency Virus (HIV).
• The patient has an uncontrolled bleeding disorder.
• The patient has uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of enrolment.
• The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the study procedures.
• The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
• The patient has received any investigational or non-registered medicinal product (drug or vaccine) within the 30 days preceding the date of enrolment.
• For female patients: the patient is pregnant or lactating.
• The patient is unable to provide informed consent or refuse blood taking.
• The patient has any other condition which, in the opinion of the Investigators, would make the patient unsuitable for enrolment or could interfere with completion of the study.