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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01963949
• Other study ID #: SCCC
• Status: Withdrawn
• Phase: N/A
• First received: October 11, 2013
• Last updated: May 15, 2014
• Start date: October 2013

Study information

• Verified date: May 2014
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biopsy of Liver Masses	To obtain tissue from biopsy of liver masses suspicious for primary liver cancer for use in future biomarker studies.	5 years	No