Extracellular RNA Markers of Liver Disease and Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1810 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2026-07-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma Biliary Tract Cancer Cirrhosis Liver Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

* 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

* Prior solid organ transplant.
* Previous cancer history with the last 5 years (excluding non-melanoma skin cancer), participation in a treatment trial for HCC

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes