Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-28 @ 7:51 AM
Study NCT ID:
NCT04883450
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-16
First Post:
2021-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRedictiOn Algorithms for the DeTECTion of Early Stage Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood (plasma, serum and Buffy coat) and Urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-12', 'studyFirstSubmitDate': '2021-05-07', 'studyFirstSubmitQcDate': '2021-05-07', 'lastUpdatePostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of pancreatic ductal adenocarcinoma (PDAC) in the high predicted risk group', 'timeFrame': '18-Month', 'description': 'Enrolled subjects will be followed for 18 months to determine the incidence rate of PDAC'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Cancer', 'Pancreatic Ductal Adenocarcinoma (PDAC)']}, 'descriptionModule': {'briefSummary': 'Conduct a prospective study to assess the accuracy of a pancreatic cancer risk prediction model.', 'detailedDescription': 'The goal of this study is to establish a platform for development and implementation of a data-driven risk model for detection of early stage pancreatic cancer within an integrated health care setting. Patients at increased risk for pancreatic cancer as identified by the risk model will be invited to participate in a prospective study to assess the accuracy of this approach for detection of early stage pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Kaiser Permanente Southern California with at least 12 months prior to recruitment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient must have 6 months of membership\n2. Patient has a measure for weight, Hemoglobin A1C, and Alanine transaminase (ALT) within the past 6 months\n3. Patient must have an increased predicted 18-month risk of pancreatic cancer based on the PRO-TECT model\n4. Speaks English or Spanish\n\nExclusion Criteria:\n\n1. Previous or current history of pancreatic cancer\n2. Metastatic cancer\n3. Current active cancer or undergoing chemotherapy for cancer\n4. Currently pregnant or breastfeeding\n5. Class IV heart failure\n6. Cirrhosis with ascites and/or varices\n7. Currently in a skilled nursing facility or under hospice care\n8. Has metal parts or implanted devices in the body, such as a pacemaker, defibrillator, or shrapnel\n9. End stage renal disease\n10. Cognitive impairment such that the person is unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04883450', 'acronym': 'PRO-TECT', 'briefTitle': 'PRedictiOn Algorithms for the DeTECTion of Early Stage Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'PRedictiOn Algorithms for the DeTECTion of Early Stage Pancreatic Cancer', 'orgStudyIdInfo': {'id': '12135'}, 'secondaryIdInfos': [{'id': 'R01CA230442', 'link': 'https://reporter.nih.gov/quickSearch/R01CA230442', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Risk of pancreatic cancer', 'description': 'Subjects with an increased predicted 18-month risk of pancreatic cancer', 'interventionNames': ['Diagnostic Test: Magnetic resonance imaging (MRI)']}], 'interventions': [{'name': 'Magnetic resonance imaging (MRI)', 'type': 'DIAGNOSTIC_TEST', 'description': 'All enrolled participants will undergo magnetic resonance imaging (MRI) at their Baseline and 18-Month follow-up visit', 'armGroupLabels': ['Risk of pancreatic cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91101', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Southern California', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}], 'overallOfficials': [{'name': 'Bechien U Wu, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}