Chronic PancreatitisNCT00685087
A Prospective Study of Natural History of Pancreatitis
An observational study of Chronic Pancreatitis, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
To prospectively define the natural history and the clinical, laboratory and histomorphometric features of chronic pancreatitis (CP) of varying etiology. To identify clinical and laboratory parameters that correlate with the pathophysiologic state in patients with CP. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pancreatitis
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Aug 2012
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects presenting to the Pancreatitis clinic with diagnosis of pancreatitis
Who may be able to join
- Subjects with pancreatitis
Who cannot join
- Lack of consent, age <18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University Medical center
Richmond, Virginia, 23298
About this study
To prospectively define the natural history and the clinical, laboratory and histomorphometric features of chronic pancreatitis (CP) of varying etiology. To identify clinical and laboratory parameters that correlate with the pathophysiologic state in patients with CP. To quantify the behavioral abnormalities associated with CP. To determine psychological and behavioral correlates of CP disease progression and outcomes.
- Conditions
- Chronic Pancreatitis
- Keywords
- To define the natural history and the clinical, laboratory and histomorphometric features of chronic pancreatitis (CP)., To identify clinical and laboratory parameters that correlate with the pathophysiologic state in patients with CP., To quantify the behavioral abnormalities associated with CP., To determine psychological and behavioral correlates of CP disease progression and outcomes.
- Medical subject headings
- Pancreatitis, Chronic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startSep 2004
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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 only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bimaljit S Sandhu, M.D, Principal investigator, Virginia Commonwealth University Medical Center, Richmond VA 23298
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685087
- Sponsor's protocol ID
- 1-Wiggins
- Status last verified
- May 2008
- First submitted
- 23 May 2008
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Sandhu B, Vitazka P, Ferreira-Gonzalez A, Pandya A, Vachhani R, Bouhaidar D, Zfass A, Sanyal A. Presence of SPINK-1 variant alters the course of chronic pancreatitis. J Gastroenterol Hepatol. 2011 Jun;26(6):965-9. doi: 10.1111/j.1440-1746.2011.06713.x.
PubMed 21375584
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Natural History of Pancreatitis
- ClinicalTrials.gov ID
- NCT00685087
- Acronym / sponsor ID
- 1-Wiggins
- Conditions
- Chronic Pancreatitis
- Keywords
- To define the natural history and the clinical, laboratory and histomorphometric features of chronic pancreatitis (CP)., To identify clinical and laboratory parameters that correlate with the pathophysiologic state in patients with CP., To quantify the behavioral abnormalities associated with CP., To determine psychological and behavioral correlates of CP disease progression and outcomes.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 28 May 2008 (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.
To prospectively define the natural history and the clinical, laboratory and histomorphometric features of chronic pancreatitis (CP) of varying etiology. To identify clinical and laboratory parameters that correlate with the pathophysiologic state in patients with CP. To quantify the behavioral abnormalities associated with CP. To determine psychological and behavioral correlates of CP disease progression and outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects presenting to the Pancreatitis clinic with diagnosis of pancreatitis
Key inclusion criteria (1 listed)
- Subjects with pancreatitis
Key exclusion criteria (1 listed)
- Lack of consent, age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 21 May 2013.
- Derived from this study: PubMed 21375584Sandhu B, Vitazka P, Ferreira-Gonzalez A, Pandya A, Vachhani R, Bouhaidar D, Zfass A, Sanyal A. Presence of SPINK-1 variant alters the course of chronic pancreatitis. J Gastroenterol Hepatol. 2011 Jun;26(6):965-9. doi: 10.1111/j.1440-1746.2011.06713.x.
Related trials for Chronic Pancreatitis
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
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.
Bimaljit S Sandhu, M.D principal investigator
Virginia Commonwealth University Medical Center, Richmond VA 23298
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 Chronic Pancreatitis, run by Virginia Commonwealth University 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 1 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 21 May 2013. 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 NCT00685087, which also lists 1 linked publication.
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 21 May 2013.