NCT02917759

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 9, 2026

Status Verified

April 1, 2025

Enrollment Period

11.8 years

First QC Date

September 24, 2016

Last Update Submit

January 7, 2026

Conditions

Keywords

liver cancerbiliary tract cancercholangiocarcinomahepatocellular carcinomaliver tumorbiliary tumorhepatomaliver mass

Outcome Measures

Primary Outcomes (1)

  • Number of successful xenografts established

    The number of successful individual patient derived xenografts that are established beyond the second passage in immunodeficient mice

    6 months

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and tissue samples

MeSH Terms

Conditions

Carcinoma, HepatocellularCholangiocarcinomaLiver NeoplasmsBiliary Tract Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesBiliary Tract Diseases

Study Officials

  • Tushar C Patel, MBChB

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

September 24, 2016

First Posted

September 28, 2016

Study Start

February 1, 2014

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 9, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations