EsophaCap for the Detection of Early Esophageal Carcinoma

Johns Hopkins University

Status: Enrolling

Conditions: Gastric Cancer; Esophageal Cancer; Barrett Esophagus

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04214119

R01DK118250 (U.S. NIH Grant/Contract)

IRB00072332

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

2,500 participants in 4 patient groups

Control

Description:

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

Description:

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

Esophageal carcinoma

Description:

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

Gastric cancer

Description:

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