Nerve Growth Factor in Chronic Pancreatitis | NCT01255917

Studies
Nerve Growth Factor in Chronic Pancreatitis

NCT01255917

Sponsor

Virginia Commonwealth University

Status

Completed

Last Update Posted

Mar 7, 2016Estimated

Enrollment

38Actual

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

Mar 2016

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

Feb 2008

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Dec 6, 2010

First Submission Date that Met QC Criteria

Dec 7, 2010

First Posted Date

Dec 8, 2010Estimated

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

Mar 3, 2016

Last Update Posted Date

Mar 7, 2016Estimated

Name	Class
Stanford University	OTHER

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

This study is to understand the role of nerve growth factor(NGF) and other cytokines in the pancreatic fluid of patients with chronic pancreatitis.

Hypothesis:

Pain does not correlate with changes in the PD morphology suggesting that pain in CP is not only a mechanical problem
Pain in CP correlates better with the levels of NGF in the pancreatic juice. NGF is variably expressed in different morphological stages of CP and regulates the sensitivity of the peptidergic nociceptors and is upregulated in pancreatic inflammation.

Detailed Description

Not provided

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

Retention

Enrollment

38Actual

Label	Type	Description	Intervention Names
Chronic pancreatitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The levels of NGF in subjects with different morphological stages of chronic pancreatitis (CP) will be compared to the controls and in each morphological stage of CP will be correlated with pain scores.		5 years

Secondary Outcomes

Measure	Description	Time Frame
Correlate the expression of NGF and other inflammatory cytokines in the pancreatic juice in each morphological stage of CP.		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with established CP and none of the exclusion criteria mention below.

Exclusion Criteria:

Failure to obtain consent.
Any comorbid condition with expected survival < 1 year.
Patients with pacemaker, implanted metallic prosthesis or other contraindications to do MRCP.
Patients < 18 years of age at time of consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Test group: Subjects with CP in each morphological stage and matched for age, race, gender, narcotic dependence and etiology of CP will be enrolled Controls: Subjects undergoing upper gastrointestinal endoscopy (UGIE) for non-pancreatic causes.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bimaljit S Sandhu, M.D	Associate Professor, VCU Medical Center	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D050500	Pancreatitis, Chronic

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided