Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-05 @ 3:40 PM
Study NCT ID:
NCT02206360
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2014-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pancreatic Cancer Early Detection Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'C535837', 'term': 'Pancreatic carcinoma, familial'}, {'id': 'D003123', 'term': 'Colorectal Neoplasms, Hereditary Nonpolyposis'}, {'id': 'C537262', 'term': 'Hereditary pancreatitis'}, {'id': 'D004416', 'term': 'Dysplastic Nevus Syndrome'}, {'id': 'D010580', 'term': 'Peutz-Jeghers Syndrome'}], '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'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009506', 'term': 'Nevus'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D044483', 'term': 'Intestinal Polyposis'}, {'id': 'D007911', 'term': 'Lentigo'}, {'id': 'D008548', 'term': 'Melanosis'}, {'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061765', 'term': 'Endoscopic Ultrasound-Guided Fine Needle Aspiration'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D044963', 'term': 'Biopsy, Fine-Needle'}, {'id': 'D001707', 'term': 'Biopsy, Needle'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D061705', 'term': 'Image-Guided Biopsy'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D018084', 'term': 'Ultrasonography, Interventional'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2014-07-29', 'studyFirstSubmitQcDate': '2014-07-30', 'lastUpdatePostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Premalignant or malignant pancreatic conditions found with alternating EUS and MRI testing.', 'timeFrame': '5 years', 'description': 'Number of Participants with Premalignant or Malignant Pancreatic Conditions, as a Measure of Safety and Efficacy'}], 'secondaryOutcomes': [{'measure': 'Clinical outcomes which occur as a result of this Protocol', 'timeFrame': '5 years', 'description': 'Prospective collection and reporting of any malignant conditions which occur as a result of this Protocol, including from surgery, or other testing.'}, {'measure': 'Complications of any interventions as a result of this Protocol', 'timeFrame': '5 years', 'description': 'Prospective collection and reporting of any complications that may be associated with early detection testing, including hospitalization, disability, and death.'}, {'measure': 'Non-Pancreatic cancers diagnosed while on this protocol', 'timeFrame': '5 years', 'description': 'Prospective collection and reporting of non-pancreatic cancers detected during this Protocol, including pancreatic cysts.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pancreatic Cancer', 'Pancreatic Cancer Screening', 'Pancreas Cancer', 'Pancreatic Adenocarcinoma', 'Pancreatic Adenocarcinoma screening', 'Familial Pancreatic Cancer', 'BRCA 1/2', 'HNPCC', 'Lynch Syndrome', 'Hereditary Pancreatitis', 'FAMMM', 'Familial atypical multiple mole melanoma', 'Peutz Jeghers Syndrome', 'MRI', 'Magnetic Resonance Imaging', 'EUS', 'Endoscopic Ultrasound', 'Early detection', 'Screening'], 'conditions': ['Pancreatic Cancer', 'Pancreas Cancer', 'Pancreatic Adenocarcinoma', 'Familial Pancreatic Cancer', 'BRCA 1/2', 'HNPCC', 'Lynch Syndrome', 'Hereditary Pancreatitis', 'FAMMM', 'Familial Atypical Multiple Mole Melanoma', 'Peutz Jeghers Syndrome']}, 'referencesModule': {'references': [{'pmid': '37099777', 'type': 'DERIVED', 'citation': 'Raff JP, Cook B, Jafri FN, Boxer N, Maldonado J, Hopkins U, Roayaie S, Noyer C. Successful Pancreatic Cancer Screening Among Individuals at Elevated Risk Using Endoscopic Ultrasound and Magnetic Resonance Imaging: A Community Hospital Experience. Pancreas. 2022 Nov-Dec 01;51(10):1345-1351. doi: 10.1097/MPA.0000000000002182.'}]}, 'descriptionModule': {'briefSummary': 'Early detection testing is recommended for individuals at elevated risk for the development of Pancreatic Cancer. This Protocol will define sufficiently elevated risk as either equal to or greater than five times the general population risk, or five times the average risk (1.5%) of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk. Our inclusion criteria has a strong focus on the risk for pancreatic cancer imparted by the presence of hereditary cancer genes, as well as by family history. Enrolled subjects will undergo Endoscopic Ultrasound (EUS) alternating with Magnetic Resonance Imaging (MRI), every six to 12 months, for up to 5 years.', 'detailedDescription': 'Interested individuals can be referred by physicians, or by family or friends.\n\nIndividuals are informed that the purpose of this study is to collect outcome data following early detection testing based upon our criteria for elevated risk.\n\nConsent is obtained by any of the co-investigators. Consent is obtained for the primary PCEDP, and also obtained to allow for data to be used by our Cancer Program.\n\nWe have a weekly review of all calls made and of all enrollments.\n\nWe have a monthly meeting to review all proceeding regarding the study.\n\nOur IRB routinely reviews the proceedings of the study\n\nOur institution has a monthly Clinical research Committee meeting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals aged 18 and older, who carry sufficiently elevated risk for the development of pancreatic cancer, numerically defined as over (or near) 5 times the general population risk, as determined by their personal, familial, or genetic history.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Any of the following:\n\n1. Known carrier of either the BRCA2 or CDKN2A mutation;\n2. Known carrier of any of the following mutations (BRCA1, MLH1, MSH2, PMS2, MSH6, EPCAM , P53, PALB2, APC, or ATM) PLUS first or second degree relative affected with pancreatic cancer;\n3. Individual with Peutz-Jeghers Syndrome;\n4. Familial Pancreatic Cancer, defined as at least two affected relatives with Pancreatic Cancer, who are first degree relatives with each other, and at least one of those affected must be first degree relative to the study subject;\n5. Both parents affected, any age:\n6. Any first degree relative diagnosed with pancreatic cancer under age 50;\n7. Chronic Pancreatitis Syndrome, defined by either PRSS1 or SPINK1 mutations AND appropriate clinical and family history\n\nExclusion Criteria:\n\n1. Any medical condition that contraindicates endoscopy or biopsy\n2. Any medical condition that contraindicates MRI\n3. Status post partial or complete resection of the pancreas\n4. History of pancreatic cancer, either endocrine or exocrine\n5. Clinical suspicion of pancreatic cancer, or any previous radiographic or histologic diagnosis of a pre-malignant finding, including IPMN (Intraductal papillary mucinous neoplasm) and PanIN (Pancreatic intraepithelial Neoplasm).\n6. diagnosis of dementia\n7. Uncontrolled, current illness\n8. Renal insufficiency with serum creatinine greater than 2.0 mg/dl'}, 'identificationModule': {'nctId': 'NCT02206360', 'acronym': 'PCEDP', 'briefTitle': 'Pancreatic Cancer Early Detection Program', 'organization': {'class': 'OTHER', 'fullName': 'White Plains Hospital'}, 'officialTitle': 'Observational Study to Analyze the Outcomes of Subjects Who - Based Upon Their Sufficiently Elevated Risk for the Development of Pancreatic Adenocarcinoma- Elect to Undergo Early Detection Testing', 'orgStudyIdInfo': {'id': 'WPH 1401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individuals at elevated risk for pancreatic cancer', 'description': 'Individuals with an elevated risk of developing pancreatic cancer as either equal to or greater than five times the general population risk, or five times the average risk (1.5%) of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk.', 'interventionNames': ['Procedure: Endoscopic Ultrasound', 'Procedure: Magnetic Resonance Imaging (MRI)']}], 'interventions': [{'name': 'Endoscopic Ultrasound', 'type': 'PROCEDURE', 'armGroupLabels': ['Individuals at elevated risk for pancreatic cancer']}, {'name': 'Magnetic Resonance Imaging (MRI)', 'type': 'PROCEDURE', 'armGroupLabels': ['Individuals at elevated risk for pancreatic cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10601', 'city': 'White Plains', 'state': 'New York', 'country': 'United States', 'facility': 'White Plains Hospital', 'geoPoint': {'lat': 41.03399, 'lon': -73.76291}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'White Plains Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Digestive Cancer Program, Center for Cancer Care', 'investigatorFullName': 'Joshua Raff, MD', 'investigatorAffiliation': 'White Plains Hospital'}}}}