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

Resectable Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04856046
• Other study ID #: 21-000878
• Secondary ID: NCI-2021-02991
• Status: Recruiting
• Start date: November 6, 2021
• Est. completion date: May 15, 2027

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: May 15, 2027
• Est. primary completion date: May 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Resectable Hepatocellular Carcinoma

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood sample

Other:
• Electronic Health Record Review
Review of medical records

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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