EsophaCap for the Detection of Early Esophageal Carcinoma
Summary
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.
Detailed description
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.
Arms & interventions
Outcome measures
Primary
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 day
Secondary
Sensitivity of candidate biomarker p16
Time frame: 1 day
Sensitivity of candidate biomarker NELL1
Time frame: 1 day
Sensitivity of candidate biomarker AKAP12
Time frame: 1 day
Sensitivity of candidate biomarker TAC1
Time frame: 1 day
Sensitivity of candidate biomarker HPP1
Time frame: 1 day
Specificity of candidate biomarker p16
Time frame: 1 day
Specificity of candidate biomarker NELL1
Time frame: 1 day
Specificity of candidate biomarker AKAP12
Time frame: 1 day
Specificity of candidate biomarker TAC1
Time frame: 1 day
Specificity of candidate biomarker HPP1
Time frame: 1 day
Eligibility criteria
Study locations (2)
Bayview Medical Center
Baltimore, Maryland, 21205
Johns Hopkins Hospital
Baltimore, Maryland, 21205