A Prospective Study of Natural History of Pancreatitis | NCT00685087

Studies
A Prospective Study of Natural History of Pancreatitis

NCT00685087

Sponsor

Virginia Commonwealth University

Status

Completed

Last Update Posted

May 21, 2013Estimated

Enrollment

300Actual

Phase

Not provided

Conditions

Chronic Pancreatitis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

May 23, 2008

First Submission Date that Met QC Criteria

May 27, 2008

First Posted Date

May 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2013

Last Update Posted Date

May 21, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. To quantify the behavioral abnormalities associated with CP. To determine psychological and behavioral correlates of CP disease progression and outcomes.

Detailed Description

Not provided

Conditions Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with pancreatitis

Exclusion Criteria:

Lack of consent, age <18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects presenting to the Pancreatitis clinic with diagnosis of pancreatitis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bimaljit S Sandhu, M.D	Virginia Commonwealth University Medical Center, Richmond VA 23298	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University Medical center		Richmond	Virginia	23298	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21375584	Derived	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.

ID	Term
D010195	Pancreatitis
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease