Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT03804593
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03804593
Study Brief:
Protocol Section:
NCT03804593