Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT06311032
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2024-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinician Decision Making Regarding Surveillance for Low-risk Intraductal Papillary Mucinous Neoplasms of The Pancreas
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': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-08', 'studyFirstSubmitDate': '2024-03-08', 'studyFirstSubmitQcDate': '2024-03-08', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Decisions to Stop Surveillance Imaging', 'timeFrame': 'Day 1'}, {'measure': 'Number of Decisions to Continue Surveillance Imaging', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery Risk Assessment']}, 'descriptionModule': {'briefSummary': "The main objective of this study is to determine how physicians make decisions regarding surveillance of Intraductal Papillary Mucinous Neoplasm's (IPMN) of the pancreas.", 'detailedDescription': 'The study will employ a survey design that poses physicians with a series of three clinical case vignettes. Each vignette describes an IPMN of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case.\n\nThis will be a double-blinded randomized survey study, featuring two arms. Providers will be randomized to either be provided with, or not provided with a risk stratification tool (DART-1) when presented with their clinical case vignettes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The Pancreatic Cancer Early Detection (PRECEDE) Consortium is an international, multi-institutional collaborative group of experts to increase survival for pancreatic cancer patients by improving early detection, screening, risk modeling and prevention for those with a heritable risk for pancreatic cancer, through a novel model of collaboration and data sharing.\n\nThe PACYFIC group is comprised of Dutch surgeons, gastroenterologists, oncologists, radiologists, radiotherapists, and pathologists. Their common interest is to improve the prognosis of patients with pancreatic cancer, by initiating and performing research, and organizing ongoing training.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Membership in either the PACYFIC or PRECEDE consortiums\n* Physician with expertise in the management of IPMN\n* Able and willing to complete survey\n\nExclusion Criteria:\n\n* Not a member of either the PACYFIC or PRECEDE consortiums\n* Not a physician with expertise in the management of IPMN'}, 'identificationModule': {'nctId': 'NCT06311032', 'briefTitle': 'Clinician Decision Making Regarding Surveillance for Low-risk Intraductal Papillary Mucinous Neoplasms of The Pancreas', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Clinician Decision Making Regarding Surveillance for Low-risk Intraductal Papillary Mucinous Neoplasms of The Pancreas', 'orgStudyIdInfo': {'id': '22-01227'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vignettes with Risk Stratification Tool', 'description': 'Physicians will be posed with a series of three clinical case vignettes. Each vignette describes an IPMN of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case. Participants in this arm will be provided a risk stratification tool (DART-1) when presented with their clinical case vignettes.\n\nThe DART-1 is a 5-question tool which calculates the probability (%) of IPMNs without worrisome features or high-risk stigmata at diagnosis.'}, {'label': 'Vignettes without Risk Stratification Tool', 'description': 'Physicians will be posed with a series of three clinical case vignettes. Each vignette describes an IPMN of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case. Participants in this arm will be not be provided a risk stratification tool when presented with their clinical case vignettes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Greg Sacks, MD, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': 'The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Greg.Sacks@nyulangone.org. The statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Greg.Sacks@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}