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NCT Number: NCT04856046

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Resectable Hepatocellular Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has planned resection or ablation of suspected hepatocellular carcinoma
  • Patient is classified as resectable T1/T2 hepatocellular carcinoma (HCC) (solitary tumors less than or equal to 2 cm OR solitary tumors without vascular invasion > 2cm or solitary tumor with vascular invasion > 2cm, or multiple tumors, none > 5cm) OR BCLC stage A (Single lesion of ANY size or 3 nodules or less with each being 3cm or less)

Exclusion criteria

  • Patient is younger than 18 years of age
  • Females who are pregnant or attempt to become pregnant
  • Patient with significant anemia (hemoglobin [Hb] < 7g/dL)
  • Patient has known cancer outside of the liver 5 years prior to current blood collection (not including basal cell or squamous cell skin cancers)
  • Patient has had a biopsy to the target organ and/or lesion within 3 days before blood collection
  • Patient has had an intervention to completely remove current target pathology
  • Target pathology is a recurrence of previously treated HCC
  • Patient has had prior resection or ablation for target lesion
  • Patient has had prior or active chemotherapy or radiation for target lesion

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of blood sample

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Electronic Health Record Review

Other

Review of medical records

Primary outcomes

  1. Multi-target hepatocellular carcinoma blood test (mt-HBT) score

    Time frame: Up to 3 years

    Association between mt-HBT score and patient and tumor characteristics with state occupancy probability will be examined using the Cox proportional hazards model. Serial measurements of the mt-HBT score obtained on subsequent visits will be accounted for within the Cox model by treating them as time varying covariate. To assess the relative importance of the mt-HBT score to individual alpha fetoprotein (AFP) levels for the prediction of hepatocellular carcinoma (HCC) recurrence, the area under the receiver operator characteristic curve (AUC) will be compared between the mt-HBT score model and an AFP only model.

  2. Recurrence-free Survival

    Time frame: Up to 3 years

    Assessed as the time from study enrollment until recurrence of hepatocellular carcinoma (HCC).

  3. Overall Survival

    Time frame: Up to 3 years

    Assessed as the time from study enrollment until death due to any cause. Will be censored for those lost to follow up or completion of study without events.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Apr 22, 2021
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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