Biliary Tract Cancer, Cirrhosis, Hepatocellular Carcinoma, Liver Diseases
Conditions
Keywords
liver cancer, cholangiocarcinoma (CCA), cirrhosis, hepatitis, bile duct cancer, hepatocellular carcinoma (HCC), hepatobiliary carcinoma, hepatoma, liver mass
Brief summary
The study will examine and evaluate the use of extracellular RNA in blood as markers for the diagnosis of liver disease or cancer, and as markers for prediction of response to treatment or recurrence of cancer after surgery
Detailed description
The goal is to identify an extracellular RNA candidate for the detection and diagnosis of liver cancers such as hepatocellular cancer or biliary cancer, and chronic liver diseases. The use of selected exRNA biomarkers for diagnosis of hepatocellular cancer (HCC) or biliary tract cancers in patients with cirrhosis will be evaluated in a prospective case-control study. The study will create a registry of patients who have chronic liver disease, cirrhosis, liver and biliary tract cancers. A risk factor questionnaire will be administered to facilitate identification of risk factors for development of liver cancer. Patient information will be obtained from the medical record, and include demographics, medical history, liver disease, smoking and alcohol history, etiology, family history, and clinical laboratory data.
Interventions
OTHERBlood samples
Blood samples collected at varying intervals over a two to three year period.
Sponsors
Mayo Clinic
National Center for Advancing Translational Sciences (NCATS)
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Lab results from within the previous 90 days. * Diagnosis of HCC or biliary tract cancer * Diagnosis of cirrhosis based on histology, imaging, or ultrasound. * Diagnosis of a chronic liver disease without cirrhosis.
Exclusion criteria
for the HCC/biliary tract cancer group: * Prior solid organ transplant. * Previous cancer history with the last 5 years (excluding non-melanoma skin cancer), participation in a treatment trial for HCC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis of liver cancer based on tumor markers and imaging studies. | Five years | The exRNA biomarker levels in the HCC and biliary tract cancer groups will be evaluated and compared to the exRNA biomarker levels present in the other groups, cirrhosis and chronic liver disease. Statistical analysis will be used to evaluate the sensitivity and specificity of these markers for the diagnosis of cancers based on findings of liver mass, imaging characteristics, size, and extent of viable tumor on imaging, or on elevated levels of tumor markers such as alpha-fetoprotein. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTushar Patel, MBChB
Mayo Clinic
Outcome results
None listed