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

Purpose

The primary 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).

Condition	Intervention	Phase
Hepatocellular Carcinoma	Procedure: MRI Procedure: Pathology Procedure: Blood Samples	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Expression levels of beta-catenin mRNA from core needle biopsy (CNB) equivalents of resected HCC. [ Time Frame: Visit 3, approximately 7 days after screening Visit 1. ] [ Designated as safety issue: No ]
Expression levels of beta-catenin protein from core needle biopsy (CNB) equivalents of resected HCC. [ Time Frame: Visit 3, approximately 7 days after screening Visit 1. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tumor volumes from repeated MRI measurements of HCC. [ Time Frame: Visit 2, approximately 7 days after screening Visit 1. ] [ Designated as safety issue: No ]
Apparent diffusion coefficients (ADC) of tumors from repeated MRI measurements of HCC. [ Time Frame: Visit 2, approximately 7 days after screening Visit 1. ] [ Designated as safety issue: No ]
Expression levels of beta-catenin mRNA from CNB equivalents of liver adjacent to HCC. [ Time Frame: Visit 3, approximately 7 days after screening Visit 1. ] [ Designated as safety issue: No ]
Expression levels of beta-catenin protein from CNB equivalents of liver adjacent to HCC. [ Time Frame: Visit 3, approximately 7 days after screening Visit 1. ] [ Designated as safety issue: No ]
Expression levels of low density lipoprotein receptor (LDL-R) in resected HCC and adjacent liver from whole tissue sections. [ Time Frame: Visit 3, approximately 7 days after screening Visit 1. ] [ Designated as safety issue: No ]

Enrollment:	12
Study Start Date:	April 2012
Study Completion Date:	November 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Imaging Magnetic resonance imaging (MRI) of HCC tumor.	Procedure: MRI Participants undergo volumetric & diffusion weighted (DW) MRI. Participants are scanned twice, with an intervening fifteen minute walk between the scans. Procedure: Blood Samples Blood is collected from participants during screening Visit 1 - 24.5 ml, and follow up Visit 4 - 5.5 ml.
Experimental: Pathology Pathology samples from surgical resection of HCC tumor and adjacent liver.	Procedure: Pathology Participants undergo surgical resection of HCC per their defined treatment. Procedure: Blood Samples 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.
Experimental: Imaging/Pathology MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.	Procedure: MRI Participants undergo volumetric & diffusion weighted (DW) MRI. Participants are scanned twice, with an intervening fifteen minute walk between the scans. Procedure: Pathology Participants undergo surgical resection of HCC per their defined treatment. Procedure: Blood Samples 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01521780 History of Changes
Other Study ID Numbers:	0000-215
Study First Received:	December 16, 2011
Last Updated:	November 13, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Merck:

hepatocellular carcinoma
MRI
pharmacogenomics
beta-catenin

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma

Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on May 23, 2013