EsophaCap for the Detection of Early Esophageal Carcinoma

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: December 19, 2025

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, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Difference in methylation of gene markers to discriminate Barrett’s esophagus from non-pathological esophageal squamous and gastric cardia tissue.
    • Time Frame: 1 day
    • 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.
  • Difference in methylation of gene markers to discriminate esophageal carcinoma from non-pathological esophageal squamous and gastric cardia tissue.
    • Time Frame: 1 day
    • 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.
  • Difference in methylation of gene markers to discriminate gastric cancer from non-pathological esophageal squamous and gastric cardia tissue.
    • Time Frame: 1 day
    • 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.

Secondary Measures

  • Sensitivity of candidate biomarker p16
    • Time Frame: 1 day
    • Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
  • Sensitivity of candidate biomarker NELL1
    • Time Frame: 1 day
    • Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
  • Sensitivity of candidate biomarker AKAP12
    • Time Frame: 1 day
    • Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
  • Sensitivity of candidate biomarker TAC1
    • Time Frame: 1 day
    • Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
  • Sensitivity of candidate biomarker HPP1
    • Time Frame: 1 day
    • Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
  • Specificity of candidate biomarker p16
    • Time Frame: 1 day
    • Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
  • Specificity of candidate biomarker NELL1
    • Time Frame: 1 day
    • Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
  • Specificity of candidate biomarker AKAP12
    • Time Frame: 1 day
    • Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
  • Specificity of candidate biomarker TAC1
    • Time Frame: 1 day
    • Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.
  • Specificity of candidate biomarker HPP1
    • Time Frame: 1 day
    • Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Johns Hopkins University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Stephen Meltzer, M.D., Principal Investigator, Johns Hopkins University
  • Overall Contact(s)
    • Stephen J Meltzer, M.D., 4105026071, smeltzer@jhmi.edu

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