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WithdrawnNCT01963949Updated May 19, 2014

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

An observational study in Hepatocellular Carcinoma, sponsored by University of Texas Southwestern Medical Center. Withdrawn. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-05-19.

Sponsored by University of Texas Southwestern Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 90 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Hepatocellular Carcinoma
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In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

500 patients with a liver mass suspicious for HCC

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

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
0 participants (actual)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Primary Liver Cancer

    Patients that have liver masses suspicious for primary liver cancer.

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What researchers measure

Primary outcomes

  1. 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

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01963949
Lead sponsor
University of Texas Southwestern Medical Center
Responsible party
Sponsor
First posted
Oct 17, 2013
Start date
Oct 2013
Primary completion
Nov 2018 (estimated)
Last update
May 19, 2014

Study contacts

Adam Yopp, MD
principal investigator · UT Southwestern Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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