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

  • STATUS
    Recruiting
  • End date
    May 15, 2027
  • participants needed
    500
  • sponsor
    Mayo Clinic
Updated on 22 March 2022

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.

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.

Details
Condition Resectable Hepatocellular Carcinoma
Treatment biospecimen collection, Electronic Health Record Review
Clinical Study IdentifierNCT04856046
SponsorMayo Clinic
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult, age >= 18
Patients with resectable hepatocellular carcinoma

Exclusion Criteria

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
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