Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-03-01 @ 6:02 AM
Study NCT ID:
NCT03075605
Status:
COMPLETED
Last Update Posted:
2021-03-05
First Post:
2017-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PROOF: Pancreatitis-associated Risk Of Organ Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D009102', 'term': 'Multiple Organ Failure'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum and DNA and urine samples will be collected and stored without personal identifiers (e.g. using a unique laboratory number or bar code) for future research involving pancreatic diseases to include pancreatitis and pancreatic cancer. Stored biospecimens collected for htis protocol may be shared in a de-identified manner with outside investigators with the approval of the principal investigator.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 723}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-04', 'studyFirstSubmitDate': '2017-02-02', 'studyFirstSubmitQcDate': '2017-03-03', 'lastUpdatePostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe Acute Pancreatitis (defined as persistent organ failure)', 'timeFrame': '1 year', 'description': 'To compare the initial immune response in patients who developed mild vs. severe disease. To determine whether functional polymorphisms in inflammation regulating genes predicts a more severe outcome in acute pancreatitis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatitis', 'Organ Failure, Multiple']}, 'referencesModule': {'references': [{'pmid': '33955376', 'type': 'DERIVED', 'citation': 'Langmead C, Lee PJ, Paragomi P, Greer P, Stello K, Hart PA, Whitcomb DC, Papachristou GI. A Novel 5-Cytokine Panel Outperforms Conventional Predictive Markers of Persistent Organ Failure in Acute Pancreatitis. Clin Transl Gastroenterol. 2021 May 6;12(5):e00351. doi: 10.14309/ctg.0000000000000351.'}, {'pmid': '32877220', 'type': 'DERIVED', 'citation': 'Komara NL, Paragomi P, Greer PJ, Wilson AS, Breze C, Papachristou GI, Whitcomb DC. Severe acute pancreatitis: capillary permeability model linking systemic inflammation to multiorgan failure. Am J Physiol Gastrointest Liver Physiol. 2020 Nov 1;319(5):G573-G583. doi: 10.1152/ajpgi.00285.2020. Epub 2020 Sep 2.'}, {'pmid': '30569031', 'type': 'DERIVED', 'citation': "Dugum M, Gougol A, Paragomi P, Gao X, Matta B, Yazici C, Tang G, Greer P, Pothoulakis I, O'Keefe SJD, Whitcomb DC, Yadav D, Papachristou GI. Association of Dietary Habits with Severity of Acute Pancreatitis. Curr Dev Nutr. 2018 Oct 8;2(12):nzy075. doi: 10.1093/cdn/nzy075. eCollection 2018 Dec."}]}, 'descriptionModule': {'briefSummary': 'This is a prospective case control study that compares the initial immune response with severity and outcome in patients with acute pancreatitis.', 'detailedDescription': 'This is a prospective case control study that compares the initial immune response with severity and outcome in patients with acute pancreatitis. Therefore, the investigators aim to determine whether etiology of acute pancreatitis, segregates with candidate genetic polymorphisms and their m-RNA expression, as well as whether functional polymorphisms in inflammation regulating genes predict a more severe outcome in acute pancreatits. The investigators anticipate that based on our results that we will provide a more accurate predictor of the clinical course of acute pancreatits and help direct more aggressive or cytokine specific treatment of patients at greater risk of a more severe form of the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Both males and females, over 1 year of age.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria for Subjects (all three) Males and females of 16 years of age and older. Body weight at least 40kg\n\nDiagnosis of acute pancreatitis by both: Abdominal pain or abdominal localizing signs AND Elevated amylase levels by at-least three times the upper limit of normal and/or elevated lipase levels by at-least three times the upper limit of normal (25, 26). Acute pancreatitis must be defined by 2 of the 3 following criteria:\n\n* Serum amylase or lipase elevated greater than 3X upper limit of normal\n* epigastric acute pancreatitis pain\n* abdominal imaging studies demonstrating pancreatic edema, peripancreatic fat stranding or complications or acute pancreatitis Willingness to participate in the study and sign the informed consent. (Children and subjects who are cognitively impaired for temporary reasons as mentioned in the section 4.7 of this protocol will require a representative to sign the informed consent).\n\nInclusion criteria for Controls (all three) Males and females of 18 years of age and older. a. Unrelated family member or a friend of the subject or a patient having blood drawn in general medicine outpatient clinic, without a history of pancreatitis, OR Willingness to participate in the study and sign the informed consent.\n\nAdditional Inclusion Criteria for subjects with a previous attack of acute pancreatitis:\n\nage criteria as defined above.\n\n\\- Previous severe attack of severe acute pancreatitis requiring a ICU stay of at least 48 hours or evidence of pancreatic necrosis on computerized tomography.\n\nWillingness to participate and sign informed consent\n\nExclusion Criteria:\n\n* Exclusion Criteria for Subjects:\n\nPersons unwilling to sign the informed consent Disorientation secondary to irreversible organic brain damage. Mean corpuscular volume (MCV) of less than 77 in all children of 18 years or younger.\n\nBlood transfusion within one week of enrollment Chronic Pancreatitis History of pancreatic cancer History of cancer requiring chemotherapy or radiation within the past 1 year History of organ transplant Subject is a prisoner Pancreatitis due to multiple trauma or surgical complications\n\nExclusion criteria for Controls:\n\nPersons unwilling to sign the informed consent'}, 'identificationModule': {'nctId': 'NCT03075605', 'acronym': 'PROOF', 'briefTitle': 'PROOF: Pancreatitis-associated Risk Of Organ Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'PROOF: Pancreatitis-associated Risk Of Organ Failure', 'orgStudyIdInfo': {'id': 'PRO08010374'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects with acute pancreatitis', 'description': 'Subjects with acute pancreatitis'}, {'label': 'Subjects with previous attack', 'description': 'Subjects with previous attack'}, {'label': 'Controls', 'description': 'Controls'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'George Papachristou, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'If shared, all individual identifiers will be removed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'David Whitcomb', 'investigatorAffiliation': 'University of Pittsburgh'}}}}