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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK118250 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study is to identify potential biomarkers for the early detection of Barrett's Esophagus, esophageal carcinoma (both adenocarcinoma and squamous cell carcinoma), and gastric cancer via sponge cytology.
This study is to identify potential biomarkers for the early detection of Barrett's Esophagus, esophageal carcinoma (both adenocarcinoma and squamous cell carcinoma). Esophageal and gastric cytology will be collected via sponge capsule. Candidate genes will be tested with DNA isolated from these samples in order to identify optimal biomarkers to differentiate between Barrett's esophagus and esophageal/gastric cancer versus normal esophageal/gastric tissue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Patients age 18 or greater who have undergone esophagogastroduodenoscopy and does not have a diagnosis of Barrett's esophagus or esophageal/gastric malignancy. | ||
| Barrett's esophagus | Patients age 18 or greater who have undergone esophagogastroduodenoscopy and diagnosed with Barrett's esophagus via pathology. | ||
| Esophageal carcinoma | Patients age 18 or greater who have diagnosis of primary esophageal carcinoma. | ||
| Gastric cancer | Patients age 18 or greater who have diagnosis of primary esophageal cancer. |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference in methylation of gene markers to discriminate Barrett's esophagus from non-pathological esophageal squamous and gastric cardia tissue. | Using DNA methylation, we plan on identifying, from a pool of highly selected marker candidates, the best biomarkers that are aberrantly methylated in Barrett's esophagus versus control in order to differentiate between subjects who have Barrett's esophagus and those who do not have Barrett's esophagus. This is measure using methylation index and the calculated probability score from different methylation index values. | 1 day |
| Difference in methylation of gene markers to discriminate esophageal carcinoma from non-pathological esophageal squamous and gastric cardia tissue. | Using DNA methylation, we plan on identifying, from a pool of highly selected marker candidates, the best biomarkers that are aberrantly methylated in esophageal cancer versus control in order to differentiate between subjects who have esophageal cancer and those who do not. This is measure using methylation index and the calculated probability score from different methylation index values. | 1 day |
| Difference in methylation of gene markers to discriminate gastric cancer from non-pathological esophageal squamous and gastric cardia tissue. | Using DNA methylation, we plan on identifying, from a pool of highly selected marker candidates, the best biomarkers that are aberrantly methylated in gastric cancer versus control in order to differentiate between subjects who have gastric cancer and those who do not. This is measure using methylation index and the calculated probability score from different methylation index values. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of candidate biomarker p16 | Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data. | 1 day |
| Sensitivity of candidate biomarker NELL1 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for clinically indicated upper endoscopy will be approached to participate in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephen J Meltzer, M.D. | Contact | 4105026071 | smeltzer@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stephen Meltzer, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bayview Medical Center | Recruiting | Baltimore | Maryland | 21205 | United States |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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Esophageal and gastric brush cells.
Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data. |
| 1 day |
| Sensitivity of candidate biomarker AKAP12 | Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data. | 1 day |
| Sensitivity of candidate biomarker TAC1 | Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data. | 1 day |
| Sensitivity of candidate biomarker HPP1 | Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data. | 1 day |
| Specificity of candidate biomarker p16 | Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data. | 1 day |
| Specificity of candidate biomarker NELL1 | Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data. | 1 day |
| Specificity of candidate biomarker AKAP12 | Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data. | 1 day |
| Specificity of candidate biomarker TAC1 | Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data. | 1 day |
| Specificity of candidate biomarker HPP1 | Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data. | 1 day |
| Johns Hopkins Hospital | Recruiting | Baltimore | Maryland | 21205 | United States |
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| D004066 |
| Digestive System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D013272 | Stomach Diseases |