Prospective Cohort Study of Changes in Circulatory MicroRNA of Resected Hepatocellular Carcinoma (PROSECT)

February 28, 2024 updated by: National Cancer Centre, Singapore

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore, 169608
        • Recruiting
        • Singapore General Hospital
        • Contact:
          • Brian GOH, MD
      • Singapore, Singapore, 308433
        • Recruiting
        • Tan Tock Seng Hospital
        • Contact:
          • Vishalkumar Girishchandra SHELAT, MD
      • Singapore, Singapore, 119228
        • Recruiting
        • National University Hospital
        • Contact:
          • Glenn Kunnath BONNEY, MD
      • Singapore, Singapore, 529889
        • Recruiting
        • Changi General Hospital
        • Contact:
          • Adrian CHIOW, MD
      • Singapore, Singapore, 544886
        • Recruiting
        • Sengkang General Hospital
        • Contact:
          • Juinn Huar KAM, MD
      • Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre Singapore
        • Contact:
          • Pierce CHOW, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
miRNA biomarker signatures diagnostic for HCC or for recurrence prediction.
Time Frame: Baseline and every 6 monthly thereafter, up to 12 months.
Changes in the profile of circulating micro-RNA biomarkers pre- and post- surgical resection.
Baseline and every 6 monthly thereafter, up to 12 months.
Metabolome profiling for recurrence prediction.
Time Frame: Baseline and every 6 monthly thereafter, up to 12 months.
Changes in the profile of metabolome in urine and plasma pre- and post- surgical resection.
Baseline and every 6 monthly thereafter, up to 12 months.
Gut microbiome profiling for recurrence prediction.
Time Frame: Baseline and every 6 monthly thereafter, up to 12 months.
Differences in the profile of gut microbiota among HCC and healthy population retrieved from database.
Baseline and every 6 monthly thereafter, up to 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Centre, Singapore

Collaborators

Nanyang Technological University
Duke-NUS Graduate Medical School
MiRXES Pte Ltd
Singapore Phenome Centre
Asian Microbiome Library (AMiLi) Pte Ltd

Investigators

  • Principal Investigator: Pierce CHOW, MD, PhD, National Cancer Centre, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2021

Primary Completion (Estimated)

February 21, 2025

Study Completion (Estimated)

February 21, 2025

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

December 2, 2021

First Posted (Actual)

December 8, 2021

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHCC11 PROSECT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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