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

NCT01963949 | Withdrawn

• 1 other identifier: SCCC
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

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.

  5 years

Study Arms (1)

Primary Liver Cancer

Patients that have liver masses suspicious for primary liver cancer.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

500 patients with a liver mass suspicious for HCC

You may qualify if:

• Liver mass suspicious for primary liver cancer with a diagnostic liver biopsy planned as a part of clinical care
• Age ≥ 18 years.
• ECOG performance status 0-2
• Adequate organ and marrow function as defined below:
• INR ≤ 1.5 platelets ≥ 70,000/mcl
• Ability to understand and the willingness to sign a written informed consent
• Target liver mass not subcapsular in nature as determined by the participating biopsy team
• Child Pugh Turcotte score A or B

You may not qualify if:

• Previous treatment for HCC
• Any contraindication for clinical-care liver biopsy, including anti-coagulation therapy that cannot be discontinued prior to biopsy or large volume ascites

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

To collect tumor tissue from patients with liver masses suspicious for primary liver cancer.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Adam Yopp, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 17, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2018
• Last Updated: May 19, 2014

Record last verified: 2014-05