Liver and Biliary Tumor Tissue Registry
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02917759|
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : December 7, 2018
|Condition or disease|
|Hepatocellular Carcinoma Cholangiocarcinoma|
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 [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Establishment of a Tissue and Blood Registry to Support Translational Investigations Into the Biology, Etiology and Therapy of Liver and Biliary Tumors|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||February 2024|
|Estimated Study Completion Date :||February 2024|
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.
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.
- 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
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02917759
|Contact: Lori Chase||904-953-3464||Chase.Lori@mayo.edu|
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|Contact: Lori Chase 904-953-3464 Chase.Lori@mayo.edu|
|Principal Investigator: Tushar C Patel, MBChB|
|Sub-Investigator: John A Copland, PhD|
|Principal Investigator:||Tushar C Patel, MBChB||Mayo Clinic|