EsophaCap for the Detection of Early Esophageal Carcinoma

December 15, 2025 updated by: Johns Hopkins University
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 Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Bayview Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for clinically indicated upper endoscopy will be approached to participate in this study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day
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.
1 day
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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Stephen Meltzer, M.D., Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2016

Primary Completion (Estimated)

December 19, 2028

Study Completion (Estimated)

December 19, 2028

Study Registration Dates

First Submitted

December 26, 2019

First Submitted That Met QC Criteria

December 26, 2019

First Posted (Actual)

January 2, 2020

Study Record Updates

Last Update Posted (Estimated)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00072332
  • R01DK118250 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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