Hepatocellular Carcinoma Clinical Trial
Official title:
HCCBloodTest for Detection of Hepatocellular Carcinoma (HCC): Marker Performance Validation and Technical Development Study
This is a multi-center study to prospectively gather clinically-characterized plasma samples to determine the diagnostic performance characteristics (sensitivity and specificity) of the HCCBloodTest among patients with cirrhosis with and without HCC
Patients with clinically-diagnosed cirrhosis without HCC (Group 1) and patients with
early-stage HCC (Group 2) will be invited to participate in this study consisting of one
visit for all subjects. At Visit 1, Day 0, after subjects have provided informed consent and
HIPAA consent, demographics (age, gender, ethnicity), etiology of liver disease and medical
history as well as a list of current medications will be obtained; inclusion and exclusion
criteria will be reviewed; and subjects will be registered into the study and will undergo a
venipuncture to obtain four (4) lavender top K2 ethylenediaminetetraacetic acid (EDTA) 10
millilitre (mL) tubes of blood.
The HCCBloodTest will be performed on the blood samples collected from study subjects by the
Sponsor at its laboratory in Berlin, Germany, to determine the performance characteristics of
the HCCBloodTest in the study population.
The HCCBloodTest is an in-vitro polymerase chain reaction (PCR) assay for the qualitative
detection of Septin 9 gene methylation (SEPT9) in DNA isolated from 3.5 mL of patient plasma.
The SEPT9 gene is a key regulator of cell division and tumor suppressor and the
hypermethylation of the assessed marker site is associated with liver carcinogenesis.
Results from the HCCBloodTest will be not be provided to the investigators or study subjects
and, therefore, will be not be used in clinical decision-making or impact clinical care of
the study participants in any manner.
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