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View Clinical Trial (Medical Research Study)
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Early Detection of Barrett's Esophagus - NCT00081354-20889 (Clinical Trial 120805)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy120805.aspx
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| City: |
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Bethesda |
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State:
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MD |
| Zip Code: |
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20889 |
| Conditions: |
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Barrett Esophagus - Esophageal Diseases |
| Purpose: |
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Background:
The incidence rate for esophageal adenocarcinoma (EAC) has risen 10% per year over the past
two decades and is the most rapidly increasing cancer in the U.S.
Barrett's esophagus (BE), a metaplastic change from the normal squamous esophageal
epithelium to a specialized intestinal-type columnar mucosa, increases the risk of EAC by
30-125, and is considered a precursor lesion for EAC.
Individuals diagnosed with BE are currently entered into endoscopic surveillance programs to
look for dysplasia or EAC. However, only 5% of subjects diagnosed with EAC have a previous
diagnosis of BE or have been part of a surveillance program, so alternative screening
methods are needed.
Objectives:
The primary goal of this project is to identify a practical blood-based biomarker(s) that
can be used as a screening test to determine who has BE and who does not.
Secondary goals of the project are to characterize germ-line and tissue biomarkers
associated with BE, and to compare biomarkers in non-BE patients with and without GERD.
Tertiary goals are to explore associations between biomarkers in blood or tissue and
progression from BE to dysplasia or EAC, and to assess the stability of proteomic patterns
over time.
Eligibility:
This study will be conducted among patients in the Barrett's Esophagus Registry (currently
with 206 registrants) established at the National Naval Medical Center (NNMC) in Bethesda
beginning in 1992, as well as a comparison group of approximately 600 matched non-BE
patients endoscoped in the GI clinic at NNMC for other conditions.
Design:
Blood and tissue samples will be collected as well as questionnaire data on risk factors and
medications as well as GERD.
Data analyses will be based primarily on laboratory testing of newly collected esophageal
biopsies, brush samples, and blood samples, but secondarily will also include use of
archival tissue biopsy samples.
Follow up of BE Registry patients will include standard periodic surveillance endoscopies,
additional blood samples, and ascertainment of disease status (i.e., progression).
To distinguish BE versus non BE-patients in this case-control study, we will:
assess predictability of BE status from serum proteomic patterns;
characterize esophageal biopsies and brush samples for selected DNA alterations, RNA
expression, and proteomic profiles;
genotype patients for selected polymorphisms potentially associated with BE;
compare blood and ...
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| Study summary: |
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Background:
The incidence rate for esophageal adenocarcinoma (EAC) has risen 10% per year over the past
two decades and is the most rapidly increasing cancer in the U.S.
Barrett's esophagus (BE), a metaplastic change from the normal squamous esophageal
epithelium to a specialized intestinal-type columnar mucosa, increases the risk of EAC by
30-125, and is considered a precursor lesion for EAC.
Individuals diagnosed with BE are currently entered into endoscopic surveillance programs to
look for dysplasia or EAC. However, only 5% of subjects diagnosed with EAC have a previous
diagnosis of BE or have been part of a surveillance program, so alternative screening
methods are needed.
Objectives:
The primary goal of this project is to identify a practical blood-based biomarker(s) that
can be used as a screening test to determine who has BE and who does not.
Secondary goals of the project are to characterize germ-line and tissue biomarkers
associated with BE, and to compare biomarkers in non-BE patients with and without GERD.
Tertiary goals are to explore associations between biomarkers in blood or tissue and
progression from BE to dysplasia or EAC, and to assess the stability of proteomic patterns
over time.
Eligibility:
This study will be conducted among patients in the Barrett's Esophagus Registry (currently
with 206 registrants) established at the National Naval Medical Center (NNMC) in Bethesda
beginning in 1992, as well as a comparison group of approximately 600 matched non-BE
patients endoscoped in the GI clinic at NNMC for other conditions.
Design:
Blood and tissue samples will be collected as well as questionnaire data on risk factors and
medications as well as GERD.
Data analyses will be based primarily on laboratory testing of newly collected esophageal
biopsies, brush samples, and blood samples, but secondarily will also include use of
archival tissue biopsy samples.
Follow up of BE Registry patients will include standard periodic surveillance endoscopies,
additional blood samples, and ascertainment of disease status (i.e., progression).
To distinguish BE versus non BE-patients in this case-control study, we will:
assess predictability of BE status from serum proteomic patterns;
characterize esophageal biopsies and brush samples for selected DNA alterations, RNA
expression, and proteomic profiles;
genotype patients for selected polymorphisms potentially associated with BE;
compare blood and tissue biomarkers in non-BE patients with and without GERD;
explore the association of biomarkers with progression from BE to dysplasia or EAC;
assess proteomic pattern stability over time in BE patients. |
| Criteria: |
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- INCLUSION CRITERIA
Inclusion criteria for EGD in this study include:
Greater than or equal to 18 years of age, and
presence of GERD or GERD-like symptoms, or
presence of BE, or
dysphagia, or
anemia, or
gastreointestinal bleeding, or
presence of other conditions (e.g., dyspepsia) that merit endoscopic evaluation.
EXCLUSION CRITERIA
Exclusion criteria for EGD in this study include:
severe pulmonary or cardiac disease, or
pregnancy, or
refusal, or
inability or refusal to give consent, or
age less than 18 years or participation in NNMC Barrett's esophagus cryotherapy protocol,
or
malignancy other than nonmelanoma skin cancer. |
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| Study is available at: |
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National Naval Medical Center
Bethesda, MD 20889
United States
Primary Contact:
NCI Referral Office
Email: ncicssc@mail.nih.gov
Phone: 1-888-NCI-1937 |
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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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