Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-01-07 @ 12:10 PM
Study NCT ID:
NCT02917759
Status:
RECRUITING
Last Update Posted:
2025-04-06
First Post:
2016-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liver and Biliary Tumor Tissue Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood and tissue samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2016-09-24', 'studyFirstSubmitQcDate': '2016-09-26', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of successful xenografts established', 'timeFrame': '6 months', 'description': 'The number of successful individual patient derived xenografts that are established beyond the second passage in immunodeficient mice'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['liver cancer', 'biliary tract cancer', 'cholangiocarcinoma', 'hepatocellular carcinoma', 'liver tumor', 'biliary tumor', 'hepatoma', 'liver mass'], 'conditions': ['Hepatocellular Carcinoma', 'Cholangiocarcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPatients 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.\n\nThe 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.\n\nClinical 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals undergoing surgical removal of a liver or biliary mass at Mayo Clinic Florida', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled to undergo surgical resection of a liver or biliary mass\n\nExclusion Criteria:\n\n* Under 18 years of age. Prior radiation to mass.'}, 'identificationModule': {'nctId': 'NCT02917759', 'briefTitle': 'Liver and Biliary Tumor Tissue Registry', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Establishment of a Tissue and Blood Registry to Support Translational Investigations Into the Biology, Etiology and Therapy of Liver and Biliary Tumors', 'orgStudyIdInfo': {'id': '13-006829'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hepatocellular cancer', 'description': '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.'}, {'label': 'Cholangiocarcinoma', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tushar Patel', 'role': 'CONTACT', 'email': 'patel.tushar@mayo.edu', 'phone': '904-953-3200'}, {'name': 'Tushar C Patel, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'John A Copland, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'centralContacts': [{'name': 'Tushar Patel', 'role': 'CONTACT', 'email': 'patel.tushar@mayo.edu', 'phone': '904-956-3257'}], 'overallOfficials': [{'name': 'Tushar C Patel, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Tushar Patel', 'investigatorAffiliation': 'Mayo Clinic'}}}}