Resectable Hepatocellular CarcinomaNCT04856046
Detection of Plasma DNA Methylation in Peripheral Blood From Patients With Resectable Liver Cancer
An observational study of Resectable Hepatocellular Carcinoma, run by Mayo Clinic at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Hepatocellular Carcinoma
- What is being tested?
- Biospecimen Collection and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2021to 4 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with resectable hepatocellular carcinoma
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Resectable Hepatocellular Carcinoma
- Being tested
- Biospecimen Collection, Electronic Health Record Review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood sample
Electronic Health Record ReviewOther
Review of medical records
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multi-target hepatocellular carcinoma blood test (mt-HBT) score
Association between mt-HBT score and patient and tumor characteristics with state occupancy probability will be examined using the Cox proportional hazards model. Serial measurements of the mt-HBT 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 mt-HBT score to individual alpha fetoprotein (AFP) levels for the prediction of hepatocellular carcinoma (HCC) recurrence, the area under the receiver operator characteristic curve (AUC) will be compared between the mt-HBT score model and an AFP only model.
Measured: Up to 3 years
Recurrence-free Survival
Assessed as the time from study enrollment until recurrence of hepatocellular carcinoma (HCC).
Measured: Up to 3 years
Overall Survival
Assessed as the time from study enrollment until death due to any cause. Will be censored for those lost to follow up or completion of study without events.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start6 Nov 2021
- Primary completion4 Dec 2029 (estimated)
- Study completion4 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nguyen H. Tran, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856046
- Sponsor's protocol ID
- 21-000878
- Other IDs
- NCI-2021-02991
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2021
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Plasma DNA Methylation in Peripheral Blood From Patients With Hepatocellular Carcinoma (ATHENA)
- ClinicalTrials.gov ID
- NCT04856046
- Acronym / sponsor ID
- 21-000878
- Conditions
- Resectable Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Nov 2021 (actual)
- Primary completion
- 4 Dec 2029 (estimated)
- Study completion
- 4 Dec 2029 (estimated)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (biospecimen collection, medical record review) | – | Procedure: Biospecimen Collection, Other: Electronic Health Record ReviewPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with resectable hepatocellular carcinoma
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood sample | Procedure or surgery | Observational (biospecimen collection, medical record review) |
| Electronic Health Record ReviewReview of medical records | Other | Observational (biospecimen collection, medical record review) |
Primary outcome
Multi-target hepatocellular carcinoma blood test (mt-HBT) score
Time frame: Up to 3 years
Association between mt-HBT score and patient and tumor characteristics with state occupancy probability will be examined using the Cox proportional hazards model. Serial measurements of the mt-HBT 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 mt-HBT score to individual alpha fetoprotein (AFP) levels for the prediction of hepatocellular carcinoma (HCC) recurrence, the area under the receiver operator characteristic curve (AUC) will be compared between the mt-HBT score model and an AFP only model.
Recurrence-free Survival
Time frame: Up to 3 years
Assessed as the time from study enrollment until recurrence of hepatocellular carcinoma (HCC).
Overall Survival
Time frame: Up to 3 years
Assessed as the time from study enrollment until death due to any cause. Will be censored for those lost to follow up or completion of study without events.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nguyen H. Tran, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resectable Hepatocellular Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multi-target hepatocellular carcinoma blood test (mt-HBT) score (time frame: Up to 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.