Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT01919151
Status:
UNKNOWN
Last Update Posted:
2013-08-12
First Post:
2013-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Micrometastasis in Gastrointestinal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and bone marrow cells fixated to slides or to cartridge. Some fresh frozen tumor samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-08-08', 'studyFirstSubmitDate': '2013-08-07', 'studyFirstSubmitQcDate': '2013-08-07', 'lastUpdatePostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '5 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['survival'], 'conditions': ['Pancreatic Adenocarcinoma', 'Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '33198661', 'type': 'DERIVED', 'citation': 'Hugenschmidt H, Labori KJ, Brunborg C, Verbeke CS, Seeberg LT, Bendigtsen Schirmer C, Renolen A, Borgen E, Naume B, Wiedswang G. Cytokeratin-positive cells in the bone marrow from patients with pancreatic, periampullary malignancy and benign pancreatic disease show no prognostic information. BMC Cancer. 2020 Nov 16;20(1):1107. doi: 10.1186/s12885-020-07510-z.'}, {'pmid': '30216219', 'type': 'DERIVED', 'citation': 'Hugenschmidt H, Labori KJ, Brunborg C, Verbeke CS, Seeberg LT, Schirmer CB, Renolen A, Borgen EF, Naume B, Wiedswang G. Circulating Tumor Cells are an Independent Predictor of Shorter Survival in Patients Undergoing Resection for Pancreatic and Periampullary Adenocarcinoma. Ann Surg. 2020 Mar;271(3):549-558. doi: 10.1097/SLA.0000000000003035.'}, {'pmid': '28258416', 'type': 'DERIVED', 'citation': 'Seeberg LT, Brunborg C, Waage A, Hugenschmidt H, Renolen A, Stav I, Bjornbeth BA, Borgen E, Naume B, Brudvik KW, Wiedswang G. Survival Impact of Primary Tumor Lymph Node Status and Circulating Tumor Cells in Patients with Colorectal Liver Metastases. Ann Surg Oncol. 2017 Aug;24(8):2113-2121. doi: 10.1245/s10434-017-5818-2. Epub 2017 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'Prognostic and predictive value of assessing the patients micrometastasis status in blood and bone marrow when diagnosed GI cancer. 2 different patient subgroups are currently studied, patients with cancer of the pancreas and patients with liver metastasis secondary to colorectal cancer.\n\nOur hypothesis is that patients with detective circulating tumor cells in the blood or disseminated tumour cells in their bone marrow at diagnosis have a more advanced disease than negative patients. This information may be of therapeutic interest.', 'detailedDescription': 'Oncological and overall outcome of the included patients are consecutively registrated at the out-patient clinic. At end of follow-up these survival data are analysed according to the presence of tumor cells in blood and bone marrow, and the prognostic impact of their presence are assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Gastrointestinal cancer patients:\n\n1. patients with suspected adenocarcinoma in the pancreas\n2. patients with liver metastases secondary to colorectal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histological proven adenocarcinoma of the pancreas\n2. Histological/radiological verified colorectal liver metastases\n3. Consent capable patient\n4. Signed written, informed consent\n\nExclusion Criteria:\n\n1\\. Patient'history of other malignancy"}, 'identificationModule': {'nctId': 'NCT01919151', 'briefTitle': 'Micrometastasis in Gastrointestinal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'The Process of Metastasis in Colorectal Cancer Tumour Biology and Prognostic Factors in Pancreatic Cancer', 'orgStudyIdInfo': {'id': '93-08172d6.2008.540'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gastrointestinal cancer patients', 'description': 'Patients with radiological suspected cancer in the pancreas Patients with radiological suspected colorectal liver metastasis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'state': 'Oslo County', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Gro Wiedswang, MD,PhD', 'role': 'CONTACT', 'email': 'uxgrie@ous-hf.no', 'phone': '+47 22119550'}, {'name': 'Gro Wiedswang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Gro Wiedswang, MD,PhD', 'role': 'CONTACT', 'email': 'uxgrie@ous-hf.no', 'phone': '+4722119550'}, {'name': 'Evi Faleide, MD,PhD', 'role': 'CONTACT', 'email': 'UXEVAL@us-hf.no', 'phone': '+4722118080'}], 'overallOfficials': [{'name': 'Bjørn Atle Bjørnbeth, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Oslo University Hospital, Dep of Gastrointestinal surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}