Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-03-03 @ 11:14 AM
Study NCT ID:
NCT03075618
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2017-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences (APPRENTICE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Samples will be obtained to study DNA.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 623}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-02', 'studyFirstSubmitDate': '2017-02-02', 'studyFirstSubmitQcDate': '2017-03-03', 'lastUpdatePostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with persistent organ failure as assessed by their clinical course.', 'timeFrame': '12 months', 'description': 'Evaluation of the existing risks, predictive scores, and markers of severe disease.'}, {'measure': 'Number of patients with pancreatic necrosis as assessed by their clinical course.', 'timeFrame': '12 months', 'description': 'Evaluation of the existing risks, predictive scores, and markers of severe disease.'}, {'measure': 'Number of patients with persistent organ failure as assessed by their clinical course.', 'timeFrame': '12 months', 'description': 'Evaluation of the current management and outcomes of acute pancreatitis around the world.'}, {'measure': 'Number of patients with pancreatic necrosis as assessed by their clinical course.', 'timeFrame': '12 months', 'description': 'Evaluation of the current management and outcomes of acute pancreatitis around the world.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '37428139', 'type': 'DERIVED', 'citation': 'Lee PJ, Culp S, Kamal A, Paragomi P, Pothoulakis I, Talukdar R, Kochhar R, Goenka MK, Gulla A, Gonzales J, Stevens T, Barbu S, Nawaz H, Gutierrez S, Zarnescu N, Capurso G, Easler J, Triantafyllou K, Ocampo C, de-Madaria E, Wu B, Hart PA, Akshintala VS, Singh VK, Bischof J, Buxbaum J, Pelaez M, Papachristou GI. Lactated Ringers Use in the First 24 Hours of Hospitalization Is Associated With Improved Outcomes in 999 Patients With Acute Pancreatitis. Am J Gastroenterol. 2023 Dec 1;118(12):2258-2266. doi: 10.14309/ajg.0000000000002391. Epub 2023 Jul 10.'}, {'pmid': '33604947', 'type': 'DERIVED', 'citation': 'Paragomi P, Tuft M, Pothoulakis I, Singh VK, Stevens T, Nawaz H, Easler JJ, Thakkar S, Cote GA, Lee PJ, Akshintala V, Kamal A, Gougol A, Phillips AE, Machicado JD, Whitcomb DC, Greer PJ, Buxbaum JL, Hart P, Conwell D, Tang G, Wu BU, Papachristou GI. Dynamic changes in the pancreatitis activity scoring system during hospital course in a multicenter, prospective cohort. J Gastroenterol Hepatol. 2021 Sep;36(9):2416-2423. doi: 10.1111/jgh.15430. Epub 2021 Feb 18.'}, {'pmid': '31712075', 'type': 'DERIVED', 'citation': 'Matta B, Gougol A, Gao X, Reddy N, Talukdar R, Kochhar R, Goenka MK, Gulla A, Gonzalez JA, Singh VK, Ferreira M, Stevens T, Barbu ST, Nawaz H, Gutierrez SC, Zarnescu NO, Capurso G, Easler J, Triantafyllou K, Pelaez-Luna M, Thakkar S, Ocampo C, de-Madaria E, Cote GA, Wu BU, Paragomi P, Pothoulakis I, Tang G, Papachristou GI. Worldwide Variations in Demographics, Management, and Outcomes of Acute Pancreatitis. Clin Gastroenterol Hepatol. 2020 Jun;18(7):1567-1575.e2. doi: 10.1016/j.cgh.2019.11.017. Epub 2019 Nov 9.'}]}, 'descriptionModule': {'briefSummary': 'The management of acute pancreatitis is mainly based on expert opinions; large randomized controlled trials are missing and novel therapeutic approaches are considered necessary. This study will evaluate the current management and outcomes of acute pancreatitis around the world.', 'detailedDescription': "The initial study design with discussions about the different variables to be included into the investigators' prospective database started during 2014 PancreasFest held in Pittsburgh, PA in late July 2014 under the sponsorship of Collaborative Alliance for Pancreatic Education and Research (CAPER). Following this, a datasheet with variables was created, distributed through the initial participants, and further suggestions and edits were made. The investigators now plan to move ahead with a web based seminar. All previous participants, as well as new investigators/centers that have shown interest in participating throughout the world will be invited. The webinar will be chaired by Dr. Papachristou at the University of Pittsburgh and again sponsored by CAPER. The investigators plan to discuss previous experience with collaborative, multi-continent, clinical studies in pancreas research, details of IRB submission, access and technical aspects of REDCap, and review the current datasheet for any further edits needed.\n\nFollowing this, each investigator will initiate the process of applying for approval to the Institutional Review Board of his/her center. University of Pittsburgh will share their accepted, ongoing PROOF protocol as a reference. Investigators/centers with active protocol approval will start enrolling patients. The investigators plan to have a Webinar every 3-4 months and/or schedule a working group meeting at DDW in May 2015 and/or EPC in June 2015 pending on attendance of these meetings by the investigators. Finally, the investigators will present all the above steps and the progress made by our working group in 2015 PancreasFest in Pittsburgh, PA.\n\nThe initial aim of this study is to develop a core of highly motivated investigators throughout the world and enroll large number of subjects into an Internet-based database. The study team plans to monitor data recording closely and prepare our first manuscript when we reach a critical number of patients. The future goal is to maintain this collaborative core and expand into designing randomized controlled trials addressing critical questions in the management of acute pancreatitis as well as applying for funding."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Acute Pancreatitis, ages 18 and over.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The diagnosis of AP based upon presence of two out of the three following criteria:\n\n 1. Abdominal pain typical to AP\n 2. Serum amylase or lipase levels more than three times the upper limit of normal\n 3. Imaging findings suggestive of AP\n2. Willingness to participate in the study and ability to sign informed consent by patient or his/her proxy (if unable to speak).\n\nExclusion Criteria:\n\n1. Age under 18 years\n2. Unwilling to provide consent by patient or his/her proxy\n3. Presence of pancreatic cancer\n4. Presence of chronic pancreatitis\n5. Occurrence of AP following a multiple trauma episode\n6. Having history of organ transplant\n7. Presence of any cancer which required chemotherapy or radiation therapy in the past year.'}, 'identificationModule': {'nctId': 'NCT03075618', 'acronym': 'APPRENTICE', 'briefTitle': 'Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences (APPRENTICE)', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences (APPRENTICE)', 'orgStudyIdInfo': {'id': 'PRO15040389'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute Pancreatitis', 'description': 'Patients with Acute Pancreatitis.', 'interventionNames': ['Behavioral: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'description': 'Questionnaires', 'armGroupLabels': ['Acute Pancreatitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Presbyterian', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'George Papachristou, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Findings will be shared with co-collaborators and the Collaborative Alliance for Pancreatic Education and Research.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'David Whitcomb', 'investigatorAffiliation': 'University of Pittsburgh'}}}}