Status:
COMPLETED
HCCBloodTest for Detection of Hepatocellular Carcinoma (HCC)
Lead Sponsor:
Epigenomics, Inc
Collaborating Sponsors:
Innovis LLC
Conditions:
Cirrhosis, Liver
Hepatic Cirrhosis
Eligibility:
All Genders
18+ years
Brief Summary
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 a...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 17 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2019
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT03804593
Start Date
December 17 2018
End Date
October 31 2019
Last Update
January 30 2020
Active Locations (2)
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1
USC Keck Medical Center
Los Angeles, California, United States, 90033
2
California Liver Research Institute
Pasadena, California, United States, 91105