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The North American Pancreatitis Study

NCT ID: NCT01545167

Last Updated: 2017-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2980 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreatitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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African Americans with pancreatitis

pancreatitis

blood sampling

Intervention Type GENETIC

blood samples obtained to extract biomarkers and dna for analysis, questionnaires

African Americans without Pancreatitis controls

people without pancreatitis

blood sampling

Intervention Type GENETIC

blood samples obtained to extract biomarkers and dna for analysis, questionnaires

Interventions

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blood sampling

blood samples obtained to extract biomarkers and dna for analysis, questionnaires

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

African American

pancreatitis patients who are at least 14 years of age with a diagnosis of acute or chronic pancreatitis

* controls who do not have pancreatitis and must be at least 18 years of age

Exclusion Criteria

* unable or unwilling to sign informed consent
Minimum Eligible Age

14 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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David Whitcomb

Chief, Division of Gastroenterology, Hepatology and Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34793964 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34236339 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32681239 (View on PubMed)

Other Identifiers

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NAPS2-AS

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DK 061451

Identifier Type: -

Identifier Source: org_study_id