EsophaCap for the Detection of Early Esophageal Carcinoma

NCT ID: NCT04214119

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-12

Study Completion Date

2028-12-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Barrett Esophagus Esophageal Cancer Gastric Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control

Patients age 18 or greater who have undergone esophagogastroduodenoscopy and does not have a diagnosis of Barrett's esophagus or esophageal/gastric malignancy.

No interventions assigned to this group

Barrett's esophagus

Patients age 18 or greater who have undergone esophagogastroduodenoscopy and diagnosed with Barrett's esophagus via pathology.

No interventions assigned to this group

Esophageal carcinoma

Patients age 18 or greater who have diagnosis of primary esophageal carcinoma.

No interventions assigned to this group

Gastric cancer

Patients age 18 or greater who have diagnosis of primary esophageal cancer.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Meltzer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Bayview Medical Center

Baltimore, Maryland, United States

Site Status RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Stephen J Meltzer, M.D.

Role: CONTACT

4105026071

Facility Contacts

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Stephen J Meltzer, M.D.

Role: primary

410-502-6071

Stephen Meltzer, M.D.

Role: primary

410-502-6071

Other Identifiers

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R01DK118250

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00072332

Identifier Type: -

Identifier Source: org_study_id