Nerve Growth Factor in Chronic Pancreatitis
This study is currently recruiting participants.
Verified December 2012 by Virginia Commonwealth University
Sponsor:
Virginia Commonwealth University
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
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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:
- 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.
| 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:
Genetics Home Reference related topics:
hereditary pancreatitis
MedlinePlus related topics:
Pancreatitis
Drug Information available for:
Nerve growth factor
U.S. FDA Resources
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
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 May 16, 2013