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

NCT ID: NCT01963949

Last Updated: 2014-05-19

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary Liver Cancer

Patients that have liver masses suspicious for primary liver cancer.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam Yopp, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Other Identifiers

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SCCC

Identifier Type: -

Identifier Source: org_study_id

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