EsophaCap for the Detection of Early Esophageal Carcinoma

Johns Hopkins University2,500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,500

Conditions

Barrett Esophagus Esophageal Cancer Gastric Cancer

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Patients with esophageal stents * Patients with esophageal strictures disabling passage of the capsule

Locations (2)

Bayview Medical Center

Baltimore, Maryland, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, United States

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

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 day

Central Contacts

Stephen J Meltzer, M.D.

CONTACT

4105026071 smeltzer@jhmi.edu

Data from ClinicalTrials.gov

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