HCCBloodTest for Detection of Hepatocellular Carcinoma (HCC)
Completed
Conditions studied: Cirrhosis, Liver, Hepatic Cirrhosis, Hepatocellular Carcinoma, Liver Cancer
In brief
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
Key facts
- Study ID
- NCT03804593
- Run by
- Epigenomics, Inc
- People needed
- 175
- Starts
- 2018-12-17
- Expected to finish
- 2019-10-31
- Last updated by the study team
- 2020-01-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- USC Keck Medical Center — Los Angeles, California, United States
- California Liver Research Institute — Pasadena, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.