- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01545167
The North American Pancreatitis Study (NAPS)
September 14, 2017 updated by: David Whitcomb, University of Pittsburgh
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.
Study Overview
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
2980
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 100 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
people with and without pancreatitis
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
African Americans with pancreatitis
pancreatitis
|
blood samples obtained to extract biomarkers and dna for analysis, questionnaires
|
African Americans without Pancreatitis controls
people without pancreatitis
|
blood samples obtained to extract biomarkers and dna for analysis, questionnaires
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Am J Gastroenterol. 2022 Feb 1;117(2):359.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
February 29, 2012
First Submitted That Met QC Criteria
February 29, 2012
First Posted (Estimate)
March 6, 2012
Study Record Updates
Last Update Posted (Actual)
September 15, 2017
Last Update Submitted That Met QC Criteria
September 14, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK 061451
- NAPS2-AS (Other Grant/Funding Number: R01 DK077906)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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