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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imaging | Experimental | Magnetic resonance imaging (MRI) of HCC tumor. |
|
| Pathology | Experimental | Pathology samples from surgical resection of HCC tumor and adjacent liver. |
|
| Imaging/Pathology | Experimental | MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Procedure | Participants undergo volumetric & diffusion weighted (DW) MRI. Participants are scanned twice, with an intervening fifteen minute walk between the scans. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 2, approximately 7 days after screening Visit 1. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Imaging | Magnetic resonance imaging (MRI) of Hepatocellular carcinoma (HCC) tumor. |
| FG001 | Pathology | Pathology samples from surgical resection of HCC tumor and adjacent liver. |
| FG002 | Imaging/Pathology | MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants who enrolled in the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed. | Posted | Visit 3, approximately 7 days after screening Visit 1. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Imaging | Magnetic resonance imaging (MRI) of HCC tumor. |
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The study was terminated early.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Pathology | Procedure | Participants who are undergoing surgical resection of HCC per their standard of care treatment, will submit tumor samples for biomarker analysis. |
|
| Blood Samples | Procedure | 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 | Procedure | Blood is collected from participants during screening Visit 1 - 24.5 ml, and follow up Visit 4 - 5.5 ml. |
|
| 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. | Visit 2, approximately 7 days after screening Visit 1. |
| Expression Levels of Beta-catenin mRNA From CNB Equivalents of Liver Adjacent to HCC. | 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. | Visit 3, approximately 7 days after screening Visit 1. |
| Expression Levels of Beta-catenin Protein From CNB Equivalents of Liver Adjacent to HCC. | 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. | 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. | 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. | Visit 3, approximately 7 days after screening Visit 1. |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Pathology samples from surgical resection of HCC tumor and adjacent liver.
| OG002 | Imaging/Pathology | MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver. |
|
| Primary | 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. | Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed. | Posted | Visit 3, approximately 7 days after screening Visit 1. |
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | log cm^3 | Visit 2, approximately 7 days after screening Visit 1. | Tumors | Participants |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | um^2/s | Visit 2, approximately 7 days after screening Visit 1. | Tumors | Participants |
|
|
|
|
| Secondary | Expression Levels of Beta-catenin mRNA From CNB Equivalents of Liver Adjacent to HCC. | 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. | Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed. | Posted | Visit 3, approximately 7 days after screening Visit 1. |
|
|
| Secondary | Expression Levels of Beta-catenin Protein From CNB Equivalents of Liver Adjacent to HCC. | 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. | Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed. | Posted | Visit 3, approximately 7 days after screening Visit 1. |
|
|
| Secondary | Expression Levels of Low Density Lipoprotein Receptor (LDL-R) in Resected HCC and Adjacent Liver From Whole Tissue Sections. | 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. | Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed. | Posted | Visit 3, approximately 7 days after screening Visit 1. |
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Pathology | Pathology samples from surgical resection of HCC tumor and adjacent liver. | 0 | 1 | 0 | 1 |
| EG002 | Imaging/Pathology | MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver. | 0 | 2 | 0 | 2 |
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.
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |