EsophaCap for the Detection of Early Esophageal Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Undergoing esophagogastroduodenoscopy at Johns Hopkins Hospital from 1/2016 to 12/2025
Age greater than 18 years
Patients must be able to swallow a capsule
Disqualifiers
Patients in either arm with extra-esophageal malignancies including head and neck and gastric cancer
Patients who have undergone esophagectomy
Patients who have undergone radiation to the chest
Patients who are younger than 18
Trial population
Patients scheduled for clinically indicated upper endoscopy will be approached to participate in this study.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
2,500 Participants
are grouped into 4 trial groupsGroup A: Control
Group B: Barrett's esophagus
Group C: Esophageal carcinoma
Group D: Gastric cancer
Trial outcomes
Primary outcomes
1
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 day2
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 day3
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 daySecondary outcomes
1
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.
Time frame
1 day2
Sensitivity of candidate biomarker NELL1
Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
Time frame
1 day3
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.
Time frame
1 day4
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.
Time frame
1 daySponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov