NCT03483922

HCC Screening Using DNA Methylation Changes in ctDNA

Clinical Trials on Detection of Hepatocellular Carcinoma With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC and T Cells

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 403 (actual)
• Sponsor: HKGepitherapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hepatocellular Carcinoma (HCC) is the fifth most common cancer world-wide. It is particularly prevalent in Asia, and its occurrence is highest in areas where hepatitis B is prevalent, indicating a possible causal relationship. Follow up of high-risk populations such as chronic hepatitis patients and early diagnosis of transitions from chronic hepatitis to HCC would improve cure rates. In most cases HCC is detected late resulting in increased mortality and morbidity. The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC and circulated tumor DNA in hepatocellular carcinomas patients.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ctDNA methylation in and it's Correlation wth Development and prediction of HCC	Blood sample from patients with HCC, healthy individuals and individuals with hepatitis B will be collected, and DNA will extracted from PBMC and circulated tumor DNA will be subjected to bisulfite conversion. DNA from PBMC DNA will be analyzed with primers developed for the AHNAK-STAP1 genes. Plasma samples will be subjected to EZ direct DNA extraction and bisulfite conversion kit and will be amplified with primers developed to amplify the target regions. DNA will be used for the subsequent PCR amplification with specific primer to generate PCR amplicon for sequencing using a double PCR procedure. The product of PCR reaction will be subjected to indexed MiSeq Next-Generation sequencing that will allow us quantify DNA methylation level.

Timeline

• Start date: 2018-08-20
• Primary completion: 2020-06-01
• Completion: 2020-11-01
• First posted: 2018-03-30
• Last updated: 2024-07-05
• Results posted: 2024-07-05

Locations

1 site across 1 country: Bangladesh