Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-01-01 @ 2:38 AM
Study NCT ID:
NCT05343832
Status:
UNKNOWN
Last Update Posted:
2022-05-11
First Post:
2022-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection Evaluation of a Novel Blood-based DNA Methylation Assay in Early-stage Hepatocellular Carcinoma Patients
Sponsor:
Genetron Health
Organization:
Study Overview
Official Title:
Detection Evaluation of a Novel Blood-based DNA Methylation Assay in Early-stage Hepatocellular Carcinoma Patients
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
ENROLLING_BY_INVITATION
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:
This trail is a multi-center,prospective observational study aimed to detect early-stage Hepatocellular Carcinoma by a Novel Blood-based DNA Methylation Assay(named Genetron HCC Methylation PCR Kit ). The accuracy of the kit will also be evaluated . The trail will be enroll approximately 4816 participants, including participants with HCC or benign diseases, and high risk factors for liver cancer.
Detailed Description:
Diagnostic performance evaluation:
Alpha-fetoprotein (AFP), liver ultrasound (US), dynamic contrast enhanced MRI and the kit examination will be performed on high-risk participants of primary liver cancer.
For subjects with typical imaging findings of hepatocellular carcinoma but an intrahepatic nodule diameter of ≤2 cm, an imaging study will be added to the above.
According to the clinical diagnostic criteria of primary liver cancer, the diagnostic performance of the kit, liver ultrasound examination (US) combined with alpha fetoprotein (AFP) detection will be evaluated, and the sensitivity of the kit, the kit combined with AFP, the kit combined with AFP and US, AFP combined with US screening for primary liver cancer will be compared.
Test performance evaluation:
Plasma samples of patients with and without HCC diagnosed according to the clinical diagnostic criteria of primary HCC will be collected and examined simultaneously by the kit and high-throughput human methylation sequencing (NGS sequencing).
Alpha-fetoprotein (AFP), liver ultrasound (US), dynamic contrast enhanced MRI and the kit examination will be performed on high-risk participants of primary liver cancer.
For subjects with typical imaging findings of hepatocellular carcinoma but an intrahepatic nodule diameter of ≤2 cm, an imaging study will be added to the above.
According to the clinical diagnostic criteria of primary liver cancer, the diagnostic performance of the kit, liver ultrasound examination (US) combined with alpha fetoprotein (AFP) detection will be evaluated, and the sensitivity of the kit, the kit combined with AFP, the kit combined with AFP and US, AFP combined with US screening for primary liver cancer will be compared.
Test performance evaluation:
Plasma samples of patients with and without HCC diagnosed according to the clinical diagnostic criteria of primary HCC will be collected and examined simultaneously by the kit and high-throughput human methylation sequencing (NGS sequencing).
Study Oversight
Has Oversight DMC:
False
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?: