Liver and Biliary Tumor Tissue Registry

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02917759
• Other study ID #: 13-006829
• Status: Recruiting
• Start date: February 2014
• Est. completion date: February 2029

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Tushar Patel
• Phone: 904-956-3257
• Email: patel.tushar[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 2029
• Est. primary completion date: February 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Biliary Tract Neoplasms
• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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