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

Sponsors

Lead Sponsor: Mayo Clinic

Collaborator: National Cancer Institute (NCI)

Source Mayo Clinic
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.

Detailed Description

PRIMARY OBJECTIVES: I. 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.

Overall Status Not yet recruiting
Start Date 2021-05-01
Completion Date 2027-05-15
Primary Completion Date 2026-05-15
Study Type Observational
Primary Outcome
Measure Time Frame
Determine association between the MHP score and patient and tumor characteristics Up to study completion, up to 5 years
Determine association between the MHP score and patient and tumor characteristics Up to study completion, up to 5 years
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
Enrollment 500
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Biospecimen Collection

Description: Undergo collection of blood sample

Arm Group Label: Observational (biospecimen collection, medical record review)

Intervention Type: Other

Intervention Name: Electronic Health Record Review

Description: Review of medical records

Arm Group Label: Observational (biospecimen collection, medical record review)

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

Inclusion Criteria: - Adult, age >= 18 - Patients with resectable hepatocellular carcinoma Exclusion Criteria: - 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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Nguyen H Tran Principal Investigator Mayo Clinic in Rochester
Location
Facility: Contact: Investigator: Mayo Clinic in Rochester Clinical Trials Referral Office 855-776-0015 [email protected] Nguyen H. Tran, M.D. Principal Investigator
Location Countries

United States

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

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.

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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