NCT01545167

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,980

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

February 29, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

5.8 years

First QC Date

February 29, 2012

Last Update Submit

September 14, 2017

Conditions

Pancreatitis

Keywords

African Americanspancreatitiscontrols

Study Arms (2)

African Americans with pancreatitis

pancreatitis

Genetic: blood sampling

African Americans without Pancreatitis controls

people without pancreatitis

Genetic: blood sampling

Interventions

blood samplingGENETIC

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

African Americans with pancreatitisAfrican Americans without Pancreatitis controls

Eligibility Criteria

Age14 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

people with and without pancreatitis

You may qualify if:

  • 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

You may not qualify if:

  • unable or unwilling to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

  • 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: 34793964DERIVED

  • 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: 34236339DERIVED

  • 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.

    PMID: 32681239DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and extracted biomarkers and genetic material.

MeSH Terms

Conditions

Pancreatitis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Gastroenterology, Hepatology and Nutrition

Study Record Dates

First Submitted

February 29, 2012

First Posted

March 6, 2012

Study Start

September 1, 2008

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

September 15, 2017

Record last verified: 2017-09

Locations

US(1)