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View Clinical Trial (Medical Research Study)
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Effect of Antireflux Therapy on the Expression of Genes in Patients With GERD - NCT00624546-14564 (Clinical Trial 204951)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy204951.aspx
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| City: |
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Rochester |
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State:
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NY |
| Zip Code: |
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14564 |
| Conditions: |
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GERD - Gastroesophageal Reflux |
| Purpose: |
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Although the symptomatic and epithelial (histologic and endoscopic) response to antireflux
therapy are well known and extensively studied, little is known of the genetic events
occurring in response to proton pump inhibitor therapy. Preliminary data from our laboratory
has shown, for example, that COX-2 expression is not only elevated in patients with
gastroesophageal reflux disease but also can be correlated with pathologic esophageal acid
exposure on 24 hour pH monitoring. Similar studies have suggested that antireflux surgery
may normalize COX-2 gene expression. In contrast studies following ablation of dysplastic
Barrett's epithelium have shown persistence of genetic changes associated with altered
cellular function, despite the return of the histologic appearance to normal. Several key
mediators of inflammation, metaplasia (Barrett's) and neoplasia have now been well
characterized and shown to be important factors in the pathogenesis of esophageal injury. It
is likely that successful antireflux therapy returns altered expression of these mediators
toward normal although this hypothesis remains largely unexplored. The aim of this study is
to investigate gene expression of key mediators of the spectrum of esophageal mucosal injury
and the response to antireflux therapy.
Hypothesis: Antireflux therapy (proton pump inhibitor and surgical fundoplication)
normalizes the expression of genes known to be involved in the pathogenesis of inflammation
(esophagitis), metaplasia (Barrett esophagus) and neoplasia (adenocarcinoma).
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| Study summary: |
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Aims: To determine the effects of antireflux therapy (pump inhibitor and surgical
fundoplication) on gene expression of:
1. inflammation: IL-8, IFN-g, TNF-a.
2. intestinal metaplasia: CDX-1/2, MUC2 and Sonic hedgehog.
3. Neoplasia: Cox-2, VEGF, and EGFR. |
| Criteria: |
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Inclusion Criteria:
For patients with GERD
- Patients referred for anti-reflux surgery
- On PPI therapy for at least 6 months
- Positive ambulatory pH monitoring (%time pH<4 > 4.7)
- Age greater than 18 years old.
- Both genders
For non-GERD controls
- Negative ambulatory pH monitoring OR
- Upper endoscopy performed for non-GERD symptoms.
- Age greater than 18 years old.
- Both genders
Exclusion Criteria:
- Prior foregut surgery
- Contra-indications for operation (poor clinical status, etc.)
- Contra-indications for endoscopy and biopsy (esophageal or gastric varices,
therapeutic anticoagulation with Coumadin or Heparin, etc.)
- Unwillingness to participate in all of the follow-up studies
- Pregnancy
- Patients using medications that may interfere with PPIs pharmacokinetics (sucralfate,
ketoconazole (Nizoral), ampicillin (Omnipen, Principen), digoxin (Lanoxin,
Lanoxicaps), and iron (Feosol, Mol-Iron, Fergon, Femiron).
- Patients using medications that may interfere with gene expression
(Immunosuppressants, Aspirin, NSAIDs, Corticosteroids).
- Patients with diseases that may interfere with gene expression (autoimmune diseases,
diseases that course with immunosuppression). |
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| Study is available at: |
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Strong Memorial Hospital
Rochester, NY 14564
United States
Primary Contact:
Jeffrey H Peters, MD
Email: jeffrey_peters@urmc.rochester.edu
Phone: 585-275-2725 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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