Monitoring changes in microRNA after liver cancer surgery
Prospective Cohort Study of Changes in Circulatory MicroRNA After Surgical Resection of Hepatocellular Carcinoma (HCC) (PROSECT)
This study is testing how levels of certain molecules in the body change before and after liver cancer surgery in patients with hepatocellular carcinoma to help improve early detection of the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 21 Years to 90 Years |
| Sex | All |
| Sponsor | National Cancer Centre, Singapore Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 6 sites (Singapore and 5 other locations) |
| Trial ID | NCT05148572 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients diagnosed with hepatocellular carcinoma (HCC) who are undergoing surgical resection. It aims to collect and analyze bio-samples, including blood, urine, and stool, before and after surgery to monitor changes in microRNA, metabolome, and microbiome profiles. Patients will also undergo CT scans at 6 and 12 months post-surgery to check for recurrence of cancer. The study serves as a positive control for another study aimed at developing a more effective diagnostic kit for early detection of HCC.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 90 with clinically and histologically confirmed hepatocellular carcinoma who are scheduled for liver resection.
Not a fit: Patients who have received prior anti-cancer treatments for HCC or have advanced liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surveillance methods for early detection of hepatocellular carcinoma recurrence, enhancing patient outcomes.
How similar studies have performed: Other studies have shown promise in using microRNA as biomarkers for cancer detection, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Singapore and 5 other locations
- National University Hospital — Singapore, Singapore (Recruiting)
- National Cancer Centre Singapore — Singapore, Singapore (Recruiting)
- Singapore General Hospital — Singapore, Singapore (Recruiting)
- Tan Tock Seng Hospital — Singapore, Singapore (Recruiting)
- Changi General Hospital — Singapore, Singapore (Recruiting)
- Sengkang General Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Pierce CHOW, MD, PhD — National Cancer Centre, Singapore
- Study coordinator: Pierce CHOW, MD, PhD
- Email: pierce.chow@duke-nus.edu.sg
- Phone: +65 6306 5424
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.