Ignite Creation Date:
2024-05-06 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05148572
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2021-11-16
Brief Title:
Prospective Cohort Study of Changes in Circulatory MicroRNA of Resected Hepatocellular Carcinoma
Sponsor:
National Cancer Centre Singapore
Organization:
National Cancer Centre Singapore
Study Overview
Official Title:
Prospective Cohort Study of Changes in Circulatory MicroRNA After Surgical Resection of Hepatocellular Carcinoma HCC PROSECT
Status:
RECRUITING
Status Verified Date:
2024-10
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:
PROSECT
Brief 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 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 2000 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
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
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 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