HCCBloodTest for Detection of Hepatocellular Carcinoma (HCC)
Sponsored by Epigenomics, Inc
About this trial
Last updated 6 years ago
Study ID
Epigenomics 2018-HCC-A
Status
Completed
Type
Observational
Placebo
No
Accepting
18+ Years
All Sexes
Trial Timing
Ended 7 years ago
What is this trial about?
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
What are the participation requirements?
Inclusion Criteria
* Men or women age 18 years or older;
* Able to read, understand and sign informed consent to participate in study;
* Willing and able to provide written informed consent;
* Willing and able to meet all study requirements and undergo venipuncture to provide blood samples;
* Child-Pugh Score of A or B.
Group 1:
• Diagnosis of cirrhosis and no HCC confirmed by abdominal contrast-enhanced MRI or CT study performed < 90 days prior to the date of consent or an MRI performed ≤ 45 days after Visit 1. If lesions are present, a LI-RADS score of LR-1 or LR-2.
Group 2:
• Diagnosis of HCC confirmed by abdominal contrast-enhanced MRI or CT study performed < 90 days prior to the date of consent or an MRI performed ≤ 45 days after Visit 1 with LI-RADS score of LR-5 and/or biopsy with histopathology.
Exclusion Criteria
Both Groups:
* Child-Pugh Score of C;
* Subject has undergone a colonoscopy, endoscopy or other invasive diagnostic procedure (other than venipuncture) during the 10 days prior to providing a blood sample for this study;
* Pregnancy;
* Breastfeeding;
* Currently undergoing dialysis;
* Currently receiving investigational treatments of any type;
* History of receiving any drug therapy, surgery or liver transplant for the treatment of HCC;
* Diagnosis of any non-HCC cancer (other than non-melanoma skin cancer) within past 5 years and/or currently undergoing treatment for any cancer;
* Any clinical condition, diagnosis, or social circumstance that, in the opinion of the Investigator, would be mean participation in the study would be contraindicated.