Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-01-02 @ 8:19 PM
Study NCT ID:
NCT02587793
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2015-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Culture of Residual Specimens Obtained From Aspiration of Hepatic Tumor to Predict the Prognosis of the Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'If the cultured cells can become cell lines, these cell lines will be stored.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-26', 'studyFirstSubmitDate': '2015-10-24', 'studyFirstSubmitQcDate': '2015-10-24', 'lastUpdatePostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival', 'timeFrame': 'one year', 'description': 'Correlation between the proliferative speeds of cultured cells and one year survival of the patients after aspiration of the tumor will be investigated.'}], 'secondaryOutcomes': [{'measure': 'cancer progression', 'timeFrame': 'one year', 'description': 'Correlation between the proliferative speeds of cultured cells and HCC progression one year after aspiration of the tumor will be investigated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma', 'primary culture', 'fine-needle aspiration', 'cancer-associated fibroblast'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '16509865', 'type': 'RESULT', 'citation': 'Lin ZY, Chuang WL, Chuang YH, Yu ML, Hsieh MY, Wang LY, Tsai JF. Discordant influence of amphotericin B on epirubicin cytotoxicity in primary hepatic malignant cells collected by a new primary culture technique. J Gastroenterol Hepatol. 2006 Feb;21(2):398-405. doi: 10.1111/j.1440-1746.2005.04026.x.'}, {'pmid': '25087586', 'type': 'RESULT', 'citation': 'Lin ZY, Wu CC, Chuang YH, Chuang WL. Clinical utility of a simple primary culture method in hepatocellular carcinoma patients. J Gastroenterol Hepatol. 2015 Feb;30(2):352-7. doi: 10.1111/jgh.12693.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this project is to investigate whether the proliferative speeds of cultured cells using our method can be integrated into Barcelona Clinic Liver Cancer (BCLC) staging classification for the possibility of personalized treatment and prediction the outcomes in hepatocellular carcinoma (HCC) patients.', 'detailedDescription': 'A total of at least 150 patients will be included and followed for at least one year. The proliferative speeds of cultured cells will be classified into (a) rapid proliferation of HCC cells with or without concomitant rapid proliferation of cancer-associated fibroblasts (CAFs), (b) rapid proliferation of CAFs alone, and (c) slow proliferation three groups. The definition for the rapid proliferation of cultured cells fits at least one of the following two items: (1) growth area of cultured cells at the 15th-28th day \\> two times of the growth area measured at the 14th day, or (2) growth area of cultured cells at the 15th-28th day \\> 70% growth area of the 25 cm flask. The GraphPad Prism software version 4.03 (GraphPad Software, Inc., La Jolla, CA, USA) is applied for statistical analysis. Influence of the proliferative speeds of cultured cells on survival and cancer progression will be calculated by the logrank test. The statistical significance is defined as P \\< 0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are proven to have HCC based on fine-needle aspiration of the tumor and also have residual specimens for culture are included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients are proven to have HCC based on fine-needle aspiration of the tumor.\n2. Patient have residual specimens obtained from fine-needle aspiration of the tumor.\n3. Patients agree to participate this study after fully explanation.\n\nExclusion Criteria:\n\n1. Patients are not proven to have HCC based on fine-needle aspiration of the tumor.\n2. Patient do not have residual specimens obtained from fine-needle aspiration of the tumor.\n3. Patients do not agree to participate this study after fully explanation.'}, 'identificationModule': {'nctId': 'NCT02587793', 'briefTitle': 'Primary Culture of Residual Specimens Obtained From Aspiration of Hepatic Tumor to Predict the Prognosis of the Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'orgStudyIdInfo': {'id': 'KMUH-IRB-20140182'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Barcelona Clinic Liver Cancer (BCLC) staging', 'description': 'The tumor stages of the patient are classified as BCLC stage 0, A, B, C, or D.', 'interventionNames': ['Other: not interventional study']}], 'interventions': [{'name': 'not interventional study', 'type': 'OTHER', 'armGroupLabels': ['Barcelona Clinic Liver Cancer (BCLC) staging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Zu-Yau Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zu-Yau Lin', 'investigatorAffiliation': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}}}}