Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Resectable Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (biospecimen collection, medical record review)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Electronic Health Record Review
Primary outcomes (3)
- measure
- Multi-target hepatocellular carcinoma blood test (mt-HBT) score
- timeFrame
- Up to 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available