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

Withdrawn

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT01963949
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-11
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-17
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-15
• Last Update Posted: 2014-05-19
• Primary Completion: 2018-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biopsy of Liver Masses	5 years	To obtain tissue from biopsy of liver masses suspicious for primary liver cancer for use in future biomarker studies.