Liver and Biliary Tumor Tissue Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hepatocellular Carcinoma, Cholangiocarcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to undergo surgical resection of a liver or biliary mass Exclusion Criteria: Under 18 years of age. Prior radiation to mass.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hepatocellular cancer<br>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<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver cancer, biliary tract cancer, cholangiocarcinoma, hepatocellular carcinoma, liver tumor, biliary tumor, hepatoma, liver mass