Prospective, Observational Study of Biomarkers in Liver Cancer - Identification of Actionable Events

N/AWithdrawnNCT01963949

University of Texas Southwestern Medical Center

Overview

To collect tumor tissue from patients with liver masses suspicious for primary liver cancer. The research biopsy will be used to identify biomarkers in future studies.

In this study patients are referred to the Department of Radiology for an image-guided (either CT or ultrasound) core needle biopsy of a liver mass suspicious for primary liver cancer as a part their clinical care. A written informed consent will be obtained for the clinical biopsy per standard protocol. Additional core biopsy of the liver mass will be performed for research purposes at the time of the clinical care biopsy. The additional research biopsy is not mandatory and is subject to a separate written informed consent, which will be obtained prior to the clinical biopsy.

Study Type

OBSERVATIONAL

Conditions

Hepatocellular Carcinoma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Liver mass suspicious for primary liver cancer with a diagnostic liver biopsy planned as a part of clinical care 2. Age ≥ 18 years. 3. ECOG performance status 0-2 4. Adequate organ and marrow function as defined below: INR ≤ 1.5 platelets ≥ 70,000/mcl 5. Ability to understand and the willingness to sign a written informed consent 6. Target liver mass not subcapsular in nature as determined by the participating biopsy team 7. Child Pugh Turcotte score A or B Exclusion Criteria: 1. Previous treatment for HCC 2. Any contraindication for clinical-care liver biopsy, including anti-coagulation therapy that cannot be discontinued prior to biopsy or large volume ascites

Outcomes

Primary Outcomes

Biopsy of Liver Masses

To obtain tissue from biopsy of liver masses suspicious for primary liver cancer for use in future biomarker studies.

Time frame: 5 years

Data from ClinicalTrials.gov

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