Recruiting

EsophaCap

Sponsor:

Johns Hopkins University

Code:

NCT04214119

Conditions

Barrett Esophagus

Esophageal Cancer

Gastric Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Barrett Esophagus

Esophageal Cancer

Gastric Cancer

Study ID

NCT04214119

Start date

Jan 12, 2016

Status verified date

Dec, 2025

Completion date

Dec 19, 2028

Anticipated

Primary completion date

Dec 19, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

2500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Stephen J Meltzer, M.D.

4105026071smeltzer@jhmi.edu

Locations

Bayview Medical Center

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Stephen J Meltzer, M.D.

410-502-6071smeltzer@jhmi.edu

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Stephen Meltzer, M.D.

410-502-6071smeltzer@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-12-16.