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Hepatocellular CarcinomaPROSECTNCT05148572

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

An observational study of Hepatocellular Carcinoma, run by National Cancer Centre, Singapore at 6 sites in Singapore.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 90 years
Conditions the study is for
Hepatocellular Carcinoma
How many people
101 participants
Where
6 sitesSingapore
Study dates
10 Nov 2021to 21 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with diagnosis of hepatocellular carcinoma (HCC) confirmed by histology at surgical resection.

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Singapore6 sites

  • National University Hospital

    Singapore, 119228

  • National Cancer Centre Singapore

    Singapore, 168583

  • Singapore General Hospital

    Singapore, 169608

  • Tan Tock Seng Hospital

    Singapore, 308433

  • Changi General Hospital

    Singapore, 529889

  • Sengkang General Hospital

    Singapore, 544886

Other trials in Singapore

About this study

Official title: Prospective Cohort Study of Changes in Circulatory MicroRNA After Surgical Resection of Hepatocellular Carcinoma (HCC) (PROSECT)

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.

Read the detailed description

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.

Keywords
Hepatocellular Carcinoma (HCC), Recurrence, miRNA biomarkers, Gut microbiota, Metabolites, Microbiome biomarkers, Circulating biomarkers
Medical subject headings
Carcinoma, Hepatocellular, Recurrence

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. miRNA biomarker signatures diagnostic for HCC or for recurrence prediction.

    Changes in the profile of circulating micro-RNA biomarkers pre- and post- surgical resection.

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

  2. Gut microbiome profiling for recurrence prediction.

    Differences in the profile of gut microbiota among HCC and healthy population retrieved from database.

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

  3. Metabolome profiling for recurrence prediction.

    Changes in the profile of metabolome in urine and plasma pre- and post- surgical resection.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2021
  2. Study start10 Nov 2021
  3. Primary completion30 Apr 2025
  4. Study completion21 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05148572
Sponsor's protocol ID
AHCC11 PROSECT
Acronym
PROSECT
Status last verified
Jul 2026
First submitted
16 Nov 2021
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma, run by National Cancer Centre, Singapore at 6 sites in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

miRNA biomarker signatures diagnostic for HCC or for recurrence prediction. (time frame: Baseline and every 6 monthly thereafter, up to 12 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05148572.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.

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