Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-27 @ 9:25 PM
Study NCT ID:
NCT05134961
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2021-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Outcomes After Resection of Primary Duodenal Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004379', 'term': 'Duodenal 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': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-16', 'studyFirstSubmitDate': '2021-11-16', 'studyFirstSubmitQcDate': '2021-11-16', 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year survival', 'timeFrame': 'Three years', 'description': 'Cumulative survival after three years'}], 'secondaryOutcomes': [{'measure': 'Duodenal cancer recurrence', 'timeFrame': '5 years', 'description': 'Recurrence found by computed tomography scan'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Duodenal Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the long-term outcomes after curatively intended resection of duodenal adenocarcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients subjected to resection of primary duodenal adenocarcinoma', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients subjected to resection of primary duodenal adenocarcinoma\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT05134961', 'briefTitle': 'Long-term Outcomes After Resection of Primary Duodenal Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Long-term Outcomes After Resection of Primary Duodenal Adenocarcinoma', 'orgStudyIdInfo': {'id': 'Duodenal adenocarcinoma'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing resection of primary duodenal cancer', 'description': 'Tumors comprised histologically confirmed adenocarcinomas in the duodenum excluding adenocarcinoma of the ampulla of Vater and adenocarcinomas with gastric and pancreato-biliary morphology and immunohistochemistry.', 'interventionNames': ['Procedure: Pancreaduodenectomy and possible adjuvant therapy']}], 'interventions': [{'name': 'Pancreaduodenectomy and possible adjuvant therapy', 'type': 'PROCEDURE', 'description': "Adjuvant therapy was generally offered to patients with T4 or lymph node positive disease. As no national Danish guidelines exist, patients were treated based on the oncologists' preference.", 'armGroupLabels': ['Patients undergoing resection of primary duodenal cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2400', 'city': 'Copenhagen NV', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Kristian Schaumburg Kiim'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Ph.d., DMSc', 'investigatorFullName': 'Kristian Kiim Jensen', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}