Characterization of Baseline Biomarker Variability in Participants With Hepatocellular Carcinoma (MK-0000-215)
A Clinical Study to Characterize Baseline Biomarker Variability in Participants With Hepatocellular Carcinoma for Utilization of Target Engagement and Pharmacodynamic Biomarkers in Future Phase I Trials
1 other identifier
interventional
12
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hepatocellular-carcinoma
Started Apr 2012
Shorter than P25 for phase_1 hepatocellular-carcinoma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2011
CompletedFirst Posted
Study publicly available on registry
January 31, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
October 28, 2013
CompletedNovember 2, 2015
October 1, 2015
5 months
December 16, 2011
August 14, 2013
October 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
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.
Visit 3, approximately 7 days after screening Visit 1.
Secondary Outcomes (5)
Tumor Volumes From Repeated MRI Measurements of HCC.
Visit 2, approximately 7 days after screening Visit 1.
Median Apparent Diffusion Coefficient (Median ADC) of Tumors From Repeated MRI Measurements of HCC.
Visit 2, approximately 7 days after screening Visit 1.
Expression Levels of Beta-catenin mRNA From CNB Equivalents of Liver Adjacent to HCC.
Visit 3, approximately 7 days after screening Visit 1.
Expression Levels of Beta-catenin Protein From CNB Equivalents of Liver Adjacent to HCC.
Visit 3, approximately 7 days after screening Visit 1.
Expression Levels of Low Density Lipoprotein Receptor (LDL-R) in Resected HCC and Adjacent Liver From Whole Tissue Sections.
Visit 3, approximately 7 days after screening Visit 1.
Study Arms (3)
Imaging
EXPERIMENTALMagnetic resonance imaging (MRI) of HCC tumor.
Pathology
EXPERIMENTALPathology samples from surgical resection of HCC tumor and adjacent liver.
Imaging/Pathology
EXPERIMENTALMRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
Interventions
Participants undergo volumetric \& diffusion weighted (DW) MRI. Participants are scanned twice, with an intervening fifteen minute walk between the scans.
Participants who are undergoing surgical resection of HCC per their standard of care treatment, will submit tumor samples for biomarker analysis.
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 Criteria
You may qualify if:
- Diagnosed with HCC.
- Candidate for surgical resection or has no contraindications to MRI procedures.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated early.
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2011
First Posted
January 31, 2012
Study Start
April 1, 2012
Primary Completion
September 1, 2012
Study Completion
November 1, 2012
Last Updated
November 2, 2015
Results First Posted
October 28, 2013
Record last verified: 2015-10