Ignite Creation Date:
2024-05-06 @ 4:22 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04965259
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2021-07-07
Brief Title:
Early Detection of Hepatocellular Carcinoma in a High-risk Prospective Cohort ELEGANCE
Sponsor:
National Cancer Centre Singapore
Organization:
National Cancer Centre Singapore
Study Overview
Official Title:
Early Detection of Hepatocellular Carcinoma HCC miRNA Microbiome and Imaging Biomarkers in the Evolution of Chronic Liver Disease in a High-risk Prospective Cohort ELEGANCE
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hepatocellular carcinoma HCC is the 7th most common cause of cancer death globally but only 20 are diagnosed in its early stages where cure is possible 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
This prospective study aims to address this unmet clinical need by validating a panel of circulating miRNA biomarkers to develop an in-vitro diagnostic IVD kit for the detection of early HCC in a cohort of high-risk patients
Additionally this study also aims to develop a multi-parametric MRI-based AI algorithm to quantify individual risks of developing HCC and to predict the progression of chronic liver disease in this cohort to enable targeted surveillance Lastly by identifying changes in the microbiome and metabolites as HCC develops in this cohort enables the establishment of actionable biomarkers that can prevent and predict the development of HCC
This prospective study aims to address this unmet clinical need by validating a panel of circulating miRNA biomarkers to develop an in-vitro diagnostic IVD kit for the detection of early HCC in a cohort of high-risk patients
Additionally this study also aims to develop a multi-parametric MRI-based AI algorithm to quantify individual risks of developing HCC and to predict the progression of chronic liver disease in this cohort to enable targeted surveillance Lastly by identifying changes in the microbiome and metabolites as HCC develops in this cohort enables the establishment of actionable biomarkers that can prevent and predict the development of HCC
Detailed Description:
Eligible patients will receive 6-monthly standard-of-care surveillance US serum AFP and liver function test for HCC until end of study or up to a maximum of 7 assessments 1 baseline and 6 follow-up assessments There will be an option for patients to continue to receive standard-of-care surveillance for HCC until end of study or up to 2 additional assessments Visits 8-9 whichever occurs first
Patients with elevated AFP or abnormalities detected on US will be investigated with multi-phasic CT scan or MRI to confirm or refute the diagnosis of HCC Additionally patients shall be scheduled for sequential bio-samples collection blood urine and stool and blood tests Hba1c and Lipid Panel during the course of the study
Patients with elevated AFP or abnormalities detected on US will be investigated with multi-phasic CT scan or MRI to confirm or refute the diagnosis of HCC Additionally patients shall be scheduled for sequential bio-samples collection blood urine and stool and blood tests Hba1c and Lipid Panel during the course of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None