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Active, not recruitingNCT04856046Updated Apr 24, 2026

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

An observational study in Resectable Hepatocellular Carcinoma, sponsored by Mayo Clinic. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
36
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Resectable Hepatocellular Carcinoma
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with resectable hepatocellular carcinoma

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
36 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Observational (biospecimen collection, medical record review)

    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.

    Procedure: Biospecimen Collection · Other: Electronic Health Record Review

Interventions

  • ProcedureBiospecimen Collection

    Undergo collection of blood sample

    Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

  • OtherElectronic Health Record Review

    Review of medical records

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: Up to 3 years

  2. Recurrence-free Survival

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

    Time frame: Up to 3 years

  3. Overall Survival

    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.

    Time frame: Up to 3 years

07

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04856046
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Apr 22, 2021
Start date
Nov 6, 2021
Primary completion
Dec 4, 2029 (estimated)
Completion
Dec 4, 2029 (estimated)
Last update
Apr 24, 2026

Study contacts

Nguyen H. Tran, M.D.
principal investigator · Mayo Clinic in Rochester

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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