Detection of Plasma DNA Methylation in Peripheral Blood From Patients With Resectable Liver Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVES:
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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.
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Procedure: Biospecimen Collection
Undergo collection of blood sample
Other: Electronic Health Record Review
Review of medical records
|
Outcome Measures
Primary Outcome Measures
- Determine association between the MHP score and patient and tumor characteristics [Up to study completion, up to 5 years]
Descriptive statistics will be used to measure the association between the MHP score and patient and tumor characteristics with state occupancy and probability will be examined using the Cox proportional hazards model.
- Determine association between the MHP score and patient and tumor characteristics [Up to study completion, up to 5 years]
Serial measurements of the MHP score obtained on subsequent visits will be accounted for within the Cox model by treating them as time varying covariate.
- Relative importance of the MHP score to individual alpha fetoprotein (AFP) levels for the prediction of hepatocellular carcinoma recurrence, [Up to study completion, up to 5 years]
Descriptive statistics will be used to assess the relative importance of the MHP score to individual alpha fetoprotein (AFP) levels for the prediction of hepatocellular carcinoma recurrence, the area under the receiver operator characteristic curve will be compared between the MHP score model and an AFP only model.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult, age >= 18
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Patients with resectable hepatocellular carcinoma
Exclusion Criteria:
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Females who are pregnant or attempt to become pregnant
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Patient with significant anemia (hemoglobin [Hb] < 7g/dL)
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Patient has known cancer outside of the liver 5 years prior to current blood collection (not including basal cell or squamous cell skin cancers)
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Patient has had a biopsy to the target organ and/or lesion within 3 days before blood collection
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Patient has had an intervention to completely remove current target pathology
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Nguyen H Tran, Mayo Clinic in Rochester
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-000878
- NCI-2021-02991
- 21-000878
- P30CA015083