Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-01-04 @ 10:50 PM
Study NCT ID:
NCT02175992
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2014-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life After Surgery for Pancreatic Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2014-06-25', 'studyFirstSubmitQcDate': '2014-06-25', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-related quality of life', 'timeFrame': '2 years', 'description': 'To assess the influence of pancreatic surgery for patients with a pancreatic malignancy on health-related quality of life'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patients Suspected for a Pancreatic (Pre-)Malignancy']}, 'referencesModule': {'references': [{'pmid': '29092792', 'type': 'DERIVED', 'citation': 'Heerkens HD, van Berkel L, Tseng DSJ, Monninkhof EM, van Santvoort HC, Hagendoorn J, Borel Rinkes IHM, Lips IM, Intven M, Molenaar IQ. Long-term health-related quality of life after pancreatic resection for malignancy in patients with and without severe postoperative complications. HPB (Oxford). 2018 Feb;20(2):188-195. doi: 10.1016/j.hpb.2017.09.003. Epub 2017 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'Pancreatic cancer has a high mortality rate. Patients with an intended curative resection show a median survival of 17-23 months. Therefore, quality of life is very important in this patient group. In this study, the effect of pancreatic surgery on quality of life is measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a suspected pancreatic malignancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with a suspected pancreatic malignancy\n* eligible for surgery with curative intent\n* being able to complete questionnaires in Dutch\n* age \\>=18 years\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02175992', 'briefTitle': 'Quality of Life After Surgery for Pancreatic Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Quality of Life After Surgery for Pancreatic Carcinoma', 'orgStudyIdInfo': {'id': '13/546'}}, 'contactsLocationsModule': {'locations': [{'zip': '3508 GA', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Department of Surgery, University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Quintus Molenaar, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Prof. dr. I.Q. Molenaar, MD, PhD', 'investigatorAffiliation': 'UMC Utrecht'}}}}