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

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ClinicalTrials.gov Identifier: NCT01521780
Recruitment Status : Terminated
First Posted : January 31, 2012
Results First Posted : October 28, 2013
Last Update Posted : November 2, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Hepatocellular Carcinoma
Interventions Procedure: MRI
Procedure: Pathology
Procedure: Blood Samples
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Imaging Pathology Imaging/Pathology
Hide Arm/Group Description Magnetic resonance imaging (MRI) of Hepatocellular carcinoma (HCC) tumor. Pathology samples from surgical resection of HCC tumor and adjacent liver. MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
Period Title: Overall Study
Started 9 1 2
Completed 9 1 2
Not Completed 0 0 0
Arm/Group Title All Participants
Hide Arm/Group Description Participants who enrolled in the study
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
61.4  (14.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
1
   8.3%
Male
11
  91.7%
1.Primary Outcome
Title Expression Levels of Beta-catenin mRNA From Core Needle Biopsy (CNB) Equivalents of Resected HCC.
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.
Arm/Group Title Imaging Pathology Imaging/Pathology
Hide Arm/Group Description:
Magnetic resonance imaging (MRI) of HCC tumor.
Pathology samples from surgical resection of HCC tumor and adjacent liver.
MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Expression Levels of Beta-catenin Protein From Core Needle Biopsy (CNB) Equivalents of Resected HCC.
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.
Arm/Group Title Imaging Pathology Imaging/Pathology
Hide Arm/Group Description:
Magnetic resonance imaging (MRI) of HCC tumor.
Pathology samples from surgical resection of HCC tumor and adjacent liver.
MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Tumor Volumes From Repeated MRI Measurements of HCC.
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Eleven participants underwent MRI and DW MRI scans and only ten of their tumors were deemed measurable by both readers for analysis. Participants in both the Imaging and Imaging/Pathology treatment groups were combined for this analysis, whereas participants in the Pathology only treatment group were not analyzed for this outcome measure.
Arm/Group Title Imaging and Imaging/Pathology
Hide Arm/Group Description:
Magnetic resonance imaging (MRI) of HCC tumor.
Overall Number of Participants Analyzed 11
Overall Number of Units Analyzed
Type of Units Analyzed: Tumors
10
Mean (Standard Deviation)
Unit of Measure: log cm^3
3.38  (0.235)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Imaging and Imaging/Pathology
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Within subject coefficient of variation
Estimated Value 0.0803
Confidence Interval (1-Sided) 90%
0.1163
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Median Apparent Diffusion Coefficient (Median ADC) of Tumors From Repeated MRI Measurements of HCC.
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Eleven participants underwent MRI and DW MRI scans and only eight of their tumors were deemed measurable by both readers for analysis. Participants in both the Imaging and Imaging/Pathology treatment groups were combined for this analysis, whereas participants in the Pathology only treatment group were not analyzed for this outcome measure.
Arm/Group Title Imaging and Imaging/Pathology
Hide Arm/Group Description:
Magnetic resonance imaging (MRI) of HCC tumor.
Overall Number of Participants Analyzed 11
Overall Number of Units Analyzed
Type of Units Analyzed: Tumors
8
Mean (Standard Deviation)
Unit of Measure: um^2/s
1340.56  (64.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Imaging and Imaging/Pathology
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Within subject coefficient of variation
Estimated Value 0.0555
Confidence Interval (1-Sided) 90%
0.0733
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Expression Levels of Beta-catenin mRNA From CNB Equivalents of Liver Adjacent to HCC.
Hide Description Tissues adjacent to 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 mRNA by qRT-PCR.
Time Frame Visit 3, approximately 7 days after screening Visit 1.
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.
Arm/Group Title Imaging Pathology Imaging/Pathology
Hide Arm/Group Description:
Magnetic resonance imaging (MRI) of HCC tumor.
Pathology samples from surgical resection of HCC tumor and adjacent liver.
MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Expression Levels of Beta-catenin Protein From CNB Equivalents of Liver Adjacent to HCC.
Hide Description Tissues adjacent to 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.
Arm/Group Title Imaging Pathology Imaging/Pathology
Hide Arm/Group Description:
Magnetic resonance imaging (MRI) of HCC tumor.
Pathology samples from surgical resection of HCC tumor and adjacent liver.
MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Expression Levels of Low Density Lipoprotein Receptor (LDL-R) in Resected HCC and Adjacent Liver From Whole Tissue Sections.
Hide Description Resected tumors and adjacent tissues were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for LDL-R protein by automated image analysis.
Time Frame Visit 3, approximately 7 days after screening Visit 1.
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.
Arm/Group Title Imaging Pathology Imaging/Pathology
Hide Arm/Group Description:
Magnetic resonance imaging (MRI) of HCC tumor.
Pathology samples from surgical resection of HCC tumor and adjacent liver.
MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Imaging Pathology Imaging/Pathology
Hide Arm/Group Description Magnetic resonance imaging (MRI) of HCC tumor. Pathology samples from surgical resection of HCC tumor and adjacent liver. MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
All-Cause Mortality
Imaging Pathology Imaging/Pathology
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Imaging Pathology Imaging/Pathology
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/1 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Imaging Pathology Imaging/Pathology
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/1 (0.00%)   0/2 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01521780     History of Changes
Other Study ID Numbers: 0000-215
First Submitted: December 16, 2011
First Posted: January 31, 2012
Results First Submitted: August 14, 2013
Results First Posted: October 28, 2013
Last Update Posted: November 2, 2015