Clinical trial NCT02908048: Extracellular RNA Markers of Liver Disease and Cancer
Official title: Extracellular RNA Markers of Liver Disease and Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hepatocellular Carcinoma
Biliary Tract Cancer
Cirrhosis
Liver Diseases
Keywords: liver cancer
cholangiocarcinoma (CCA)
cirrhosis
hepatitis
bile duct cancer
hepatocellular carcinoma (HCC)
hepatobiliary carcinoma
hepatoma
liver mass
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 1810
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing evaluation at Mayo Clinic Florida Liver Transplant, Surgery, Oncology or Radiology clinics who have hepatocellular carcinoma (HCC) or biliary tract cancers, cirrhosis without HCC, or chronic liver disease without cirrhosis.

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.

Eligibility 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).

Primary outcomes:
measure: Diagnosis of liver cancer based on tumor markers and imaging studies.
timeFrame: Five years
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
Study officials:
affiliation: Mayo Clinic
name: Tushar Patel, MBChB
role: PRINCIPAL_INVESTIGATOR
References: