Clinical trial NCT04856046: Detection of Plasma DNA Methylation in Peripheral Blood From Patients With Resectable Liver Cancer
Official title: Detection of Plasma DNA Methylation in Peripheral Blood From Patients With Hepatocellular Carcinoma (ATHENA)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Resectable Hepatocellular Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with resectable hepatocellular carcinoma

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Multi-target hepatocellular carcinoma panel (MHP) score
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Nguyen H. Tran, M.D.
role: PRINCIPAL_INVESTIGATOR
References: