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Trial record 70 of 170 for:    cholangiocarcinoma | Recruiting, Not yet recruiting, Available Studies

Liver and Biliary Tumor Tissue Registry

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ClinicalTrials.gov Identifier: NCT02917759
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Tushar Patel, Mayo Clinic

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.

Condition or disease
Hepatocellular Carcinoma Cholangiocarcinoma

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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


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.



Primary Outcome Measures :
  1. 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
whole blood and tissue samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Contacts
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Contact: Lori Chase 904-953-3464 Chase.Lori@mayo.edu

Locations
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United States, Florida
Mayo Clinic Recruiting
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         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Tushar C Patel, MBChB Mayo Clinic

Additional Information:

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Responsible Party: Tushar Patel, Dean for Research, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02917759     History of Changes
Other Study ID Numbers: 13-006829
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Tushar Patel, Mayo Clinic:
liver cancer
biliary tract cancer
cholangiocarcinoma
hepatocellular carcinoma
liver tumor
biliary tumor
hepatoma
liver mass

Additional relevant MeSH terms:
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Cholangiocarcinoma
Carcinoma, Hepatocellular
Biliary Tract Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Biliary Tract Diseases