Blood test for detecting liver cancer recurrence
Detection of Plasma DNA Methylation in Peripheral Blood From Patients With Hepatocellular Carcinoma (ATHENA)
This study is testing a new blood test to see if it can help find early signs of liver cancer returning in patients who are having surgery for the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04856046 on ClinicalTrials.gov |
What this trial studies
This study investigates a new blood test that aims to detect residual disease or early recurrence of liver cancer in patients who are undergoing surgery for resectable hepatocellular carcinoma. It involves collecting blood samples from patients at various intervals before and after surgery, alongside analyzing previously collected tumor tissue samples. The goal is to identify specific DNA methylation patterns in the blood that correlate with disease progression, which could enhance clinical decision-making and patient monitoring.
Who should consider this trial
Good fit: Ideal candidates are adults with planned surgical resection or ablation for resectable hepatocellular carcinoma.
Not a fit: Patients with significant anemia, those under 18 years old, or those with other cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of liver cancer recurrence, improving patient outcomes and treatment strategies.
How similar studies have performed: Other studies have explored blood-based biomarkers for cancer detection, showing promise, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Nguyen H. Tran, M.D. — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.