Actively Recruiting
EsophaCap for the Detection of Early Esophageal Carcinoma
Led by Johns Hopkins University · Updated on 2025-12-16
2500
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying biomarkers for early detection of Barrett's Esophagus, esophageal carcinoma (including adenocarcinoma and squamous cell carcinoma), and gastric cancer. The goal is to find markers that can differentiate between these conditions and normal esophageal or gastric tissue, helping to identify these diseases sooner. This observational study collects cytology samples using a sponge capsule to analyze DNA and test candidate genes as potential biomarkers. The study involves collecting esophageal and gastric cell samples through a swallowed sponge capsule. Participants include adults over 18 who have undergone esophagogastroduodenoscopy and fall into different groups: those without Barrett's esophagus or cancer, those diagnosed with Barrett's esophagus, those with esophageal carcinoma, and those with gastric cancer. The DNA from these samples will be analyzed to find differences in gene methylation that could serve as biomarkers. Participants will be assessed through the sponge capsule procedure and the analysis of collected samples. Researchers will measure differences in gene methylation to distinguish disease states from normal tissue. They will also evaluate the sensitivity and specificity of several candidate biomarkers, such as p16, NELL1, AKAP12, TAC1, and HPP1. The study is conducted over a long period, with the main outcome measurements typically done within one day after sample collection.
CONDITIONS
Brief Title
EsophaCap for the Detection of Early Esophageal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Patients 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 younger than 18 years
- Patients with esophageal stents
- Patients with esophageal strictures preventing capsule passage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo esophageal and gastric cytology collection via a sponge capsule to identify potential biomarkers for early detection of esophageal conditions.
1 visit (in-person)
Trial Site Locations
Total: 2 locations
1
Bayview Medical Center
Baltimore, Maryland, United States, 21205
Actively Recruiting
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
S
Stephen J Meltzer, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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