Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT00947102
Status:
UNKNOWN
Last Update Posted:
2010-01-13
First Post:
2009-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Gemcitabine Treatment on Immunological and Serological Profile in Patients With Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-01-12', 'studyFirstSubmitDate': '2009-07-24', 'studyFirstSubmitQcDate': '2009-07-24', 'lastUpdatePostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pancreatic tubular adenocarcinoma', 'gemcitabine', 'gene expression', 'immunological status', 'serological status', 'pancreatic tubular adenocarcinoma adjuvant setting'], 'conditions': ['Pancreatic Tubular Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'Observational study of influence of gemcitabine treatment on serological and immunological status and gene expression profile in patients with pancreatic tubular carcinoma after tumor resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients after resection of pancreatic tubular adenocarcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ECOG performance status 0-2 at the time of inclusion\n* Following R0 or R1 pancreatic tubular adenocarcinoma resection\n\nExclusion Criteria:\n\n* Pregnancy\n* Serious comorbidity'}, 'identificationModule': {'nctId': 'NCT00947102', 'acronym': 'GEMSTHER', 'briefTitle': 'Influence of Gemcitabine Treatment on Immunological and Serological Profile in Patients With Pancreatic Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Blood Transfusion Centre of Slovenia'}, 'officialTitle': 'Observational Study - Influence of Gemcitabine Treatment on Immunological and Serological Profile in Patients With Pancreatic Tubular Carcinoma', 'orgStudyIdInfo': {'id': 'Gemcitabine1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pancreatic tubular adenocarcinoma', 'description': 'Patients with pancreatic tubular adenocarcinoma', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'armGroupLabels': ['Pancreatic tubular adenocarcinoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'state': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Borut Stabuc, MD, PhD', 'role': 'CONTACT', 'email': 'borut.stabuc@kclj.si', 'phone': '+386 1 522 2210'}, {'name': 'Lojze Smid, MD', 'role': 'CONTACT', 'email': 'lojze.smid.jr@mf.uni-lj.si'}, {'name': 'Borut Stabuc, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Medical Centre Ljubljana; Department for Gastroenterology', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Borut Stabuc, MD, PhD', 'role': 'CONTACT', 'email': 'borut.stabuc@kclj.si', 'phone': '+386 1 522 22 10'}, {'name': 'Lojze Smid, MD', 'role': 'CONTACT', 'email': 'lojze.smid.jr@mf.uni-lj.si'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Blood Transfusion Centre of Slovenia', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Primoz Rozman MD, PhD', 'oldOrganization': 'Blood Transfusion Centre of Ljubljana'}}}}