PancreatitisNAPSNCT01545167
The North American Pancreatitis Study
An observational study of Pancreatitis, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatitis
- What is being tested?
- blood sampling
- How many people
- 2,980 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: people with and without pancreatitis
Who may be able to join
- 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
Who cannot join
- unable or unwilling to sign informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Pancreatitis
- Being tested
- blood sampling
- Keywords
- African Americans, pancreatitis, controls
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingGenetic
blood samples obtained to extract biomarkers and dna for analysis, questionnaires
| Study group | Role | What they receive |
|---|---|---|
| African Americans with pancreatitis | pancreatitis Receives: Genetic: blood sampling | |
| African Americans without Pancreatitis controls | people without pancreatitis Receives: Genetic: blood sampling |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startSep 2008
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,980 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Whitcomb, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545167
- Sponsor's protocol ID
- DK 061451
- Other IDs
- NAPS2-AS
- Acronym
- NAPS
- Status last verified
- Sep 2017
- First submitted
- 29 Feb 2012
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34793964Dunbar 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.
PubMed 34236339Dunbar 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.
PubMed 32681239
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The North American Pancreatitis Study
- ClinicalTrials.gov ID
- NCT01545167
- Acronym / sponsor ID
- NAPS / DK 061451
- Conditions
- Pancreatitis
- Keywords
- African Americans, pancreatitis, controls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,980 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 6 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| African Americans with pancreatitis | – | Genetic: blood samplingpancreatitis |
| African Americans without Pancreatitis controls | – | Genetic: blood samplingpeople without pancreatitis |
Who may qualify
- Ages
- 14 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- people with and without pancreatitis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- unable or unwilling to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingblood samples obtained to extract biomarkers and dna for analysis, questionnaires | Genetic | African Americans with pancreatitis, African Americans without Pancreatitis controls |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Derived from this study: PubMed 34793964Yadav 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.
- Derived from this study: PubMed 34236339Dunbar 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.
- Derived from this study: PubMed 32681239Dunbar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01545167, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.