Detection of Plasma DNA Methylation in Peripheral Blood From Patients With Resectable Liver Cancer

NCT04856046 | Active Not Recruiting

• 2 other identifiers: 21-000878NCI-2021-02991
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Resectable Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 3 years

• Recurrence-free Survival

  Assessed as the time from study enrollment until recurrence of hepatocellular carcinoma (HCC).

  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.

  Up to 3 years

Study Arms (1)

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; Other: Electronic Health Record Review

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood sample

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Observational (biospecimen collection, medical record review)

Electronic Health Record Review OTHER

Review of medical records

Observational (biospecimen collection, medical record review)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with resectable hepatocellular carcinoma

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tissue

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Nguyen H. Tran, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 22, 2021
• Study Start: November 6, 2021
• Primary Completion (Estimated): December 4, 2029
• Study Completion (Estimated): December 4, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)