ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-11-06

Study Completion:2026-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04856046

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Principal Investigator

Nguyen H. Tran, M.D.

PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Nguyen H. Tran, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-06

Study Completion Date2026-04-01

Study Record Updates

Study Start Date2021-11-06

Study Completion Date2026-04-01

Terms related to this study

Additional Relevant MeSH Terms

Resectable Hepatocellular Carcinoma