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The North American Pancreatitis Study (NAPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01545167
Recruitment Status : Completed
First Posted : March 6, 2012
Last Update Posted : September 15, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Pancreatitis Genetic: blood sampling

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 Design

Study Type : Observational
Actual Enrollment : 2980 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The North American Pancreatitis Study
Study Start Date : September 2008
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
African Americans with pancreatitis
Genetic: blood sampling
blood samples obtained to extract biomarkers and dna for analysis, questionnaires
African Americans without Pancreatitis controls
people without pancreatitis
Genetic: blood sampling
blood samples obtained to extract biomarkers and dna for analysis, questionnaires

Outcome Measures

Biospecimen Retention:   Samples With DNA
Blood samples and extracted biomarkers and genetic material.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
people with and without pancreatitis

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545167

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
More Information

Responsible Party: David Whitcomb, Chief, Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01545167     History of Changes
Other Study ID Numbers: DK 061451
NAPS2-AS ( Other Grant/Funding Number: R01 DK077906 )
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017

Keywords provided by David Whitcomb, University of Pittsburgh:
African Americans

Additional relevant MeSH terms:
Pancreatic Diseases
Digestive System Diseases