Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-29 @ 9:17 PM
Study NCT ID:
NCT00936104
Status:
COMPLETED
Last Update Posted:
2012-07-03
First Post:
2009-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Side Population in Pancreatic Ductal Adenocarcinoma (PDAC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Pancreatic cancer tissue specimen'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-01', 'studyFirstSubmitDate': '2009-07-07', 'studyFirstSubmitQcDate': '2009-07-08', 'lastUpdatePostDateStruct': {'date': '2012-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterization of side population (SP) cells in pancreatic ductal adenocarcinoma (PDAC)'}]}, 'conditionsModule': {'keywords': ['pancreas', 'cancer', 'stem cell'], 'conditions': ['Neoplasm', 'Pancreas']}, 'referencesModule': {'references': [{'pmid': '22894607', 'type': 'DERIVED', 'citation': 'Van den Broeck A, Gremeaux L, Topal B, Vankelecom H. Human pancreatic adenocarcinoma contains a side population resistant to gemcitabine. BMC Cancer. 2012 Aug 15;12:354. doi: 10.1186/1471-2407-12-354.'}]}, 'descriptionModule': {'briefSummary': "In the current project we aim to study the oncological process of pancreatic cancer, from a perspective of the CSC-theory and in particular through the 'side population' (SP)-approach. The SP seems to be enriched for CSC and doesn't a priori exclude any CSC-subpopulation. After isolation from pancreatic cancer resection specimens, SP cells will be characterized by gene-expression profiling based on microarray analysis. We'll identify markers and pathways (with emphasis for stem cell and cancer -related ones) that are differentially expressed in SP versus the rest of tumour cells (the 'main population' or MP). In order to assess the prognostic relevance of the SP, we'll study these genes using the high-throughput Nanostring technology in about 200 snap-frozen PDAC resection specimens of patients from our prospective database. Finally, two monoclonal antibodies (mAB) will be tested as novel therapeutic agents in vivo (mouse model), wherein the choice of mAB will be based on prognostically relevant molecular targets and pathways obtained from the Nanostring results."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'SP cells will be identified through incubation with vital dye Hoechst 33342 of cell suspensions that are obtained from fresh human pancreatic cancer resection specimens.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resected pancreatic ductal adenocarcinoma (PDAC)\n* Informed consent\n\nExclusion Criteria:\n\n* Age \\< 18years\n* Pregnancy\n* Pre-operative radiotherapy\n* Pre-operative chemotherapy\n* IPMT'}, 'identificationModule': {'nctId': 'NCT00936104', 'briefTitle': 'Side Population in Pancreatic Ductal Adenocarcinoma (PDAC)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gasthuisberg'}, 'officialTitle': "Prognostic and Therapeutic Relevance of the 'Side Population' in Pancreatic Cancer", 'orgStudyIdInfo': {'id': 'BT-PDAC-SP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SP in PDAC', 'description': 'Side population cells isolated from resection specimens obtained from patients with pancreatic cancer'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'facility': 'University Hospital Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gasthuisberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Baki Topal', 'investigatorAffiliation': 'University Hospital, Gasthuisberg'}}}}