Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-04 @ 9:35 AM
Study NCT ID:
NCT01545167
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2012-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The North American Pancreatitis Study
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': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples and extracted biomarkers and genetic material.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2980}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-14', 'studyFirstSubmitDate': '2012-02-29', 'studyFirstSubmitQcDate': '2012-02-29', 'lastUpdatePostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['African Americans', 'pancreatitis', 'controls'], 'conditions': ['Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '34793964', 'type': 'DERIVED', 'citation': 'Yadav D, Whitcomb DC, Tang G, Slivka A, Bellin M; North American Pancreatitis Studies Consortium. Autoimmunity May Explain Diabetes in a Subset of Patients With Recurrent Acute and Chronic Pancreatitis: A Pilot Study. Clin Gastroenterol Hepatol. 2023 Jan;21(1):226-228.e1. doi: 10.1016/j.cgh.2021.11.011. Epub 2021 Nov 16.'}, {'pmid': '34236339', 'type': 'DERIVED', 'citation': 'Dunbar EK, Greer PJ, Amann ST, Alkaade S, Banks P, Brand R, Conwell DL, Forsmark CE, Gardner TB, Guda NM, Lewis MD, Machicado JD, Muniraj T, Papachristou GI, Romagnuolo J, Sandhu BS, Sherman S, Slivka A, Wilcox CM, Yadav D, Whitcomb DC; NAPS2 Consortium. Pain Experience in Pancreatitis: Strong Association of Genetic Risk Loci for Anxiety and PTSD in Patients With Severe, Constant, and Constant-Severe Pain. Am J Gastroenterol. 2021 Oct 1;116(10):2128-2136. doi: 10.14309/ajg.0000000000001366.'}, {'pmid': '32681239', 'type': 'DERIVED', 'citation': 'Dunbar E, Greer PJ, Melhem N, Alkaade S, Amann ST, Brand R, Cote GA, Forsmark CE, Gardner TB, Gelrud A, Guda NM, LaRusch J, Lewis MD, Machicado JD, Muniraj T, Papachristou GI, Romagnuolo J, Sandhu BS, Sherman S, Wilcox CM, Singh VK, Yadav D, Whitcomb DC; NAPS2 study group. Constant-severe pain in chronic pancreatitis is associated with genetic loci for major depression in the NAPS2 cohort. J Gastroenterol. 2020 Oct;55(10):1000-1009. doi: 10.1007/s00535-020-01703-w. Epub 2020 Jul 17.'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate several genes and other factors measured in the blood that may cause recurrent acute pancreatitis and chronic pancreatitis. No treatment is offered as part of this study. Subjects have one single visit to provide a blood sample for genetic testing and to answer a questionnaire. Subjects are not given results of genetic testing. The study is currently enrolling African American subjects and controls only.', 'detailedDescription': 'This study seeks to enroll African American people with and without pancreatitis. There is only one study visit to obtain consent, a blood sample and complete a questionnaire. Subjects must be patients of a participating center; controls must present to a participating center for enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'people with and without pancreatitis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAfrican American\n\npancreatitis patients who are at least 14 years of age with a diagnosis of acute or chronic pancreatitis\n\n* controls who do not have pancreatitis and must be at least 18 years of age\n\nExclusion Criteria:\n\n* unable or unwilling to sign informed consent'}, 'identificationModule': {'nctId': 'NCT01545167', 'acronym': 'NAPS', 'briefTitle': 'The North American Pancreatitis Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'The North American Pancreatitis Study', 'orgStudyIdInfo': {'id': 'DK 061451'}, 'secondaryIdInfos': [{'id': 'NAPS2-AS', 'type': 'OTHER_GRANT', 'domain': 'R01 DK077906'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'African Americans with pancreatitis', 'description': 'pancreatitis', 'interventionNames': ['Genetic: blood sampling']}, {'label': 'African Americans without Pancreatitis controls', 'description': 'people without pancreatitis', 'interventionNames': ['Genetic: blood sampling']}], 'interventions': [{'name': 'blood sampling', 'type': 'GENETIC', 'description': 'blood samples obtained to extract biomarkers and dna for analysis, questionnaires', 'armGroupLabels': ['African Americans with pancreatitis', 'African Americans without Pancreatitis controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Division of Gastroenterology, Hepatology and Nutrition', 'investigatorFullName': 'David Whitcomb', 'investigatorAffiliation': 'University of Pittsburgh'}}}}