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

Phase 1TerminatedNCT01521780

Merck Sharp & Dohme LLC12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

MRIPROCEDURE

Participants undergo volumetric \& diffusion weighted (DW) MRI. Participants are scanned twice, with an intervening fifteen minute walk between the scans.

PathologyPROCEDURE

Participants who are undergoing surgical resection of HCC per their standard of care treatment, will submit tumor samples for biomarker analysis.

Blood SamplesPROCEDURE

Blood is collected from participants during screening Visit 1 - 24.5 ml. During Visit 3, blood samples totaling 22 ml, are collected at least 6-18 hours post-resection, and every other day up to a week until discharge. At follow up Visit 4, 5.5 ml of blood is collected.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Expression Levels of Beta-catenin mRNA From Core Needle Biopsy (CNB) Equivalents of Resected HCC.

Resected tumors were fixed with formalin in paraffin embedded (FFPE) blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin messenger RNA (mRNA) by quantitative reverse transcription polymerase chain reaction (qRT-PCR).

Time frame: Visit 3, approximately 7 days after screening Visit 1.

Expression Levels of Beta-catenin Protein From Core Needle Biopsy (CNB) Equivalents of Resected HCC.

Resected tumors were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin protein by automated image analysis.

Time frame: Visit 3, approximately 7 days after screening Visit 1.

Secondary Outcomes

Tumor Volumes From Repeated MRI Measurements of HCC.

Two volumetric MRI and diffusion weighted (DW) MRI scans were performed without contrast on each participant. The two scans were separated by 10 to 15 minutes, and each scan was read by a separate reader to determine the volume of each tumor. The mean of log tumor volume is presented, based on tumors as observation units.

Time frame: Visit 2, approximately 7 days after screening Visit 1.

Median Apparent Diffusion Coefficient (Median ADC) of Tumors From Repeated MRI Measurements of HCC.

Two volumetric MRI and diffusion weighted (DW) MRI scans were performed without contrast on each participant. The two scans were separated by 10 to 15 minutes, and each scan was read by a separate reader to derive a Median ADC for each tumor. The mean of the Median ADCs is presented based on tumours as observation units.

Time frame: Visit 2, approximately 7 days after screening Visit 1.

Expression Levels of Beta-catenin mRNA From CNB Equivalents of Liver Adjacent to HCC.

Data from ClinicalTrials.gov

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