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)

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.

Study Overview

• Status: Recruiting
• Conditions: Resectable Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: Biospecimen Collection; Other: Electronic Health Record Review

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Nguyen H. Tran, M.D.
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with resectable hepatocellular carcinoma

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; Undergo collection of blood sample; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Electronic Health Record Review; Review of medical records

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multi-target hepatocellular carcinoma panel (MHP) score	Descriptive statistics will be used. The association between the MHP score and patient and tumor characteristics with state occupancy probability will be examined using the Cox proportional hazards model. Serial measurements of the MHP 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 MHP score to individual alpha fetoprotein (AFP) levels for the prediction of hepatocellular carcinoma recurrence, the area under the receiver operator characteristic curve will be compared between the MHP score model and an AFP only model.	Up to 1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Nguyen H. Tran, M.D., Mayo Clinic in Rochester

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2021
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2027

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: 21-000878; NCI-2021-02991 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No