Extracellular RNA Markers of Liver Disease and Cancer

Mayo Clinic

Status: Active, not recruiting

Conditions: Cirrhosis; Biliary Tract Cancer; Hepatocellular Carcinoma; Liver Diseases

Treatments: Other: Blood samples

Study type: Observational

Funder types: Other

Identifiers

NCT02908048

14-004560

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,810 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion criteria for the cirrhosis and chronic liver disease groups:

• Prior solid organ transplant.
• Previous or current cancer history within the past 5 years (excluding non-melanoma skin cancer).

Trial design

1,810 participants in 4 patient groups

Hepatocellular Carcinoma

Description:

Blood samples will be collected at entry into the study and at varying intervals over a two to three year period.

Treatment:

Other: Blood samples

Biliary Tract Cancer

Description:

Blood samples will be collected at entry into the system and at varying intervals over a two to three year period.

Treatment:

Other: Blood samples

Cirrhosis

Description:

Blood samples will be collected during regular intervals over a three year period.

Treatment:

Other: Blood samples

Chronic Liver Disease without Cirrhosis

Description:

A single blood sample will be collected at entry into the study

Treatment:

Other: Blood samples