NCT01521780 — Characterization of Baseline Biomarker Variability in Participants With Hepatocellular Carcinoma (MK-0000-215) · CancerIndex

Clinical trial · Interventional

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

NCT01521780CI-TRIAL-00019672terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Hepatocellular Carcinoma	Hepatocellular Carcinoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Blood Samples	Procedure	—	UNRESOLVED
MRI	Procedure	—	UNRESOLVED
Pathology	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
Imaging
description
Magnetic resonance imaging (MRI) of HCC tumor.
interventionNames
1. Procedure: MRI
2. Procedure: Blood Samples
type
EXPERIMENTAL
label
Pathology
description
Pathology samples from surgical resection of HCC tumor and adjacent liver.
interventionNames
1. Procedure: Pathology
2. Procedure: Blood Samples
type
EXPERIMENTAL
label
Imaging/Pathology
description

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.

Primary outcomes (2)

measure
Expression Levels of Beta-catenin mRNA From Core Needle Biopsy (CNB) Equivalents of Resected HCC.
timeFrame
Visit 3, approximately 7 days after screening Visit 1.
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).
measure
Expression Levels of Beta-catenin Protein From Core Needle Biopsy (CNB) Equivalents of Resected HCC.
timeFrame
Visit 3, approximately 7 days after screening Visit 1.
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.

Secondary outcomes (5)

measure
Tumor Volumes From Repeated MRI Measurements of HCC.
timeFrame
Visit 2, approximately 7 days after screening Visit 1.
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.
measure
Median Apparent Diffusion Coefficient (Median ADC) of Tumors From Repeated MRI Measurements of HCC.
timeFrame
Visit 2, approximately 7 days after screening Visit 1.
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.
measure
Expression Levels of Beta-catenin mRNA From CNB Equivalents of Liver Adjacent to HCC.
timeFrame
Visit 3, approximately 7 days after screening Visit 1.
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.
measure
Expression Levels of Beta-catenin Protein From CNB Equivalents of Liver Adjacent to HCC.
timeFrame
Visit 3, approximately 7 days after screening Visit 1.
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.
measure
Expression Levels of Low Density Lipoprotein Receptor (LDL-R) in Resected HCC and Adjacent Liver From Whole Tissue Sections.
timeFrame
Visit 3, approximately 7 days after screening Visit 1.
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.