NCT04856046

Detection of Plasma DNA Methylation in Peripheral Blood From Patients With Resectable Liver Cancer

Detection of Plasma DNA Methylation in Peripheral Blood From Patients With Hepatocellular Carcinoma (ATHENA)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study explores the potential values of a new blood test approach to detect measurable residual disease or early coming back of cancer (recurrence)/cancer growing, spreading, or getting worse (progression) in patients with liver cancer that can be removed by surgery (resectable). The development of novel cancer biomarkers for liver cancer may help in clinical decision making and lead to improvements in patient outcomes by facilitating prediction of the response to specific treatments, improved monitoring of patients on treatment, and better prognostication of patient outcomes, thus improving stratification for clinical trials.

Detailed description

PRIMARY OBJECTIVES: I. To isolate plasma deoxyribonucleic acid (DNA) methylation panel from the peripheral blood of treated patients with hepatocellular carcinoma that will correlate with disease progression or measurable residual disease. II. To correlate the mutations/ DNA methylation in peripheral blood with those identified in parallel tumor samples from the same patients with hepatocellular (HCC). OUTLINE: Patients undergo collection of blood samples at 4-6 weeks prior to surgery/ablation and at 12 weeks, 6, 12, 18 and 24 months after surgery/ablation. Patients' previously collected tissue samples are analyzed. Patients' medical records are also reviewed at baseline, 4-6 weeks prior to surgery/ablation, 12 weeks, 6, 12, 18 and 24 months after surgery/ablation, and then every 6 months for 3 years.

Conditions

• Resectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood sample
OTHER	Electronic Health Record Review	Review of medical records

Timeline

• Start date: 2021-11-06
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2021-04-22
• Last updated: 2025-06-12

Locations

1 site across 1 country: United States