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

The University of Texas System (UT)

Status: Withdrawn

Conditions: Hepatocellular Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT01963949

SCCC

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Primary Liver Cancer

Description:

Patients that have liver masses suspicious for primary liver cancer.