Nerve Growth Factor in Chronic Pancreatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Virginia Commonwealth University
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01255917
First received: December 6, 2010
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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:

  1. Pain does not correlate with changes in the PD morphology suggesting that pain in CP is not only a mechanical problem
  2. 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.

Condition
Chronic Pancreatitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Nerve Growth Factor in Chronic Pancreatitis

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • 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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlate the expression of NGF and other inflammatory cytokines in the pancreatic juice in each morphological stage of CP. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Pancreatic fluid obtained by duodenal aspiration


Estimated Enrollment: 100
Study Start Date: February 2008
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic pancreatitis

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255917

Contacts
Contact: Bimaljit S Sandhu, M.D 8048284060 bsandhu@vcu.edu
Contact: Sheri Maters, NP 8048284060 smaters@mcvh-vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Bimaljit S Sandhu, MD    804-828-4060    bsandhu@vcu.edu   
Sponsors and Collaborators
Virginia Commonwealth University
Stanford University
Investigators
Principal Investigator: Bimaljit S Sandhu, M.D Associate Professor, VCU Medical Center
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01255917     History of Changes
Other Study ID Numbers: HM11033
Study First Received: December 6, 2010
Last Updated: December 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Tio identify role of NGF in pain in CP
Identify biomarkers related to progression of CP

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014