Characterization of Baseline Biomarker Variability in Participants With Hepatocellular Carcinoma (MK-0000-215)
NCT ID: NCT01521780
Last Updated: 2015-11-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
12 participants
INTERVENTIONAL
2012-04-30
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Imaging
Magnetic resonance imaging (MRI) of HCC tumor.
MRI
Participants undergo volumetric \& diffusion weighted (DW) MRI. Participants are scanned twice, with an intervening fifteen minute walk between the scans.
Blood Samples
Blood is collected from participants during screening Visit 1 - 24.5 ml, and follow up Visit 4 - 5.5 ml.
Pathology
Pathology samples from surgical resection of HCC tumor and adjacent liver.
Pathology
Participants who are undergoing surgical resection of HCC per their standard of care treatment, will submit tumor samples for biomarker analysis.
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.
Imaging/Pathology
MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
MRI
Participants undergo volumetric \& diffusion weighted (DW) MRI. Participants are scanned twice, with an intervening fifteen minute walk between the scans.
Pathology
Participants who are undergoing surgical resection of HCC per their standard of care treatment, will submit tumor samples for biomarker analysis.
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.
Interventions
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MRI
Participants undergo volumetric \& diffusion weighted (DW) MRI. Participants are scanned twice, with an intervening fifteen minute walk between the scans.
Pathology
Participants who are undergoing surgical resection of HCC per their standard of care treatment, will submit tumor samples for biomarker analysis.
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.
Blood Samples
Blood is collected from participants during screening Visit 1 - 24.5 ml, and follow up Visit 4 - 5.5 ml.
Eligibility Criteria
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Inclusion Criteria
* Candidate for surgical resection or has no contraindications to MRI procedures.
Exclusion Criteria
* Confirmed or suspected diagnosis of fibrolamellar HCC, mixed HCC/cholangiocarcinoma or metastatic tumor.
* Had a liver transplant.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Other Identifiers
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0000-215
Identifier Type: -
Identifier Source: org_study_id
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