Liver and Biliary Tumor Tissue Registry

January 7, 2026 updated by: Tushar Patel, Mayo Clinic

Establishment of a Tissue and Blood Registry to Support Translational Investigations Into the Biology, Etiology and Therapy of Liver and Biliary Tumors

Patients having surgery to remove a liver or biliary tissue mass or having a biopsy of a mass or lesion will have a tissue sample collected and stored for future research of liver and biliary diseases. A blood sample may also be collected at the time of enrollment.

Study Overview

Status

Terminated

Conditions

Detailed Description

The study establishes a tissue and blood registry at Mayo Clinic Florida to support translational investigations into the biology, etiology and prognosis of liver and biliary masses such as through the use of patient-derived xenografts.

Patients having surgery to remove a liver or biliary mass or having a biopsy of a mass or lesion will be asked to donate a portion of the removed mass for research purposes. Only portions of the mass not required for clinical diagnostic evaluation, or surgical waste, will be used in this research study.

The tissues acquired will be stored and used for any specific, hypothesis driven protocols that are IRB approved. Serum and plasma samples may also be obtained at enrollment.

Clinical patient data from medical charts that may be correlative to outcomes will be collected and stored in a password secure data base. Data will be extracted from medical records charts.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals undergoing surgical removal of a liver or biliary mass at Mayo Clinic Florida

Description

Inclusion Criteria:

  • Scheduled to undergo surgical resection of a liver or biliary mass

Exclusion Criteria:

  • Under 18 years of age. Prior radiation to mass.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Hepatocellular cancer
Surgical waste tissue will be collected after removal of a liver tumor. A blood sample may be collected at the time of labs related to treatment for the diagnosis. An extra sample of biopsy tissue will be collected from participants having a targeted mass biopsy.
Cholangiocarcinoma
Surgical waste tissue will be collected after removal of a biliary tumor. A blood sample may be collected at the time of labs related to treatment for the diagnosis. An extra sample of biopsy tissue will be collected from participants having a targeted mass biopsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of successful xenografts established
Time Frame: 6 months
The number of successful individual patient derived xenografts that are established beyond the second passage in immunodeficient mice
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Tushar C Patel, MBChB, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

September 24, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (Estimated)

September 28, 2016

Study Record Updates

Last Update Posted (Estimated)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-006829

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe