Characterization of Baseline Biomarker Variability in Participants With Hepatocellular Carcinoma (MK-0000-215)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: MRI; Procedure: Pathology; Procedure: Blood Samples

Study type: Interventional

Funder types: Industry

Identifiers

NCT01521780

0000-215

Details and patient eligibility

About

The purpose of this study is to characterize the baseline variability of a panel of tissue (tumor and adjacent) and blood-based biomarkers obtained from participants with hepatocellular carcinoma (HCC). The primary hypothesis is that the upper bound of the 80% Confidence Interval of log beta-catenin protein or messenger RNA (mRNA) expression from one core needle biopsy (CNB) equivalent is =< 0.65.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with HCC.
• Candidate for surgical resection or has no contraindications to MRI procedures.

Exclusion criteria

• Prior loco-regional treatment of tumor, unless there is untreated tumor present representing a distinct untreated nodule.
• Confirmed or suspected diagnosis of fibrolamellar HCC, mixed HCC/cholangiocarcinoma or metastatic tumor.
• Had a liver transplant.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Imaging

Experimental group

Description:

Magnetic resonance imaging (MRI) of HCC tumor.

Treatment:

Procedure: Blood Samples

Procedure: MRI

Procedure: Blood Samples

Pathology

Experimental group

Description:

Pathology samples from surgical resection of HCC tumor and adjacent liver.

Treatment:

Procedure: Blood Samples

Procedure: Pathology

Procedure: Blood Samples

Imaging/Pathology

Experimental group

Description:

MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.

Treatment:

Procedure: Blood Samples

Procedure: Pathology

Procedure: MRI

Procedure: Blood Samples