EsophaCap for the Detection of Early Esophageal Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Barrett Esophagus, Esophageal Cancer, Gastric Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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.
Primary outcome measures
- 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]
Secondary outcome measures (10)
- Sensitivity of candidate biomarker p16 [Time frame: 1 day]
- Sensitivity of candidate biomarker NELL1 [Time frame: 1 day]
- Sensitivity of candidate biomarker AKAP12 [Time frame: 1 day]
- Sensitivity of candidate biomarker TAC1 [Time frame: 1 day]
- Sensitivity of candidate biomarker HPP1 [Time frame: 1 day]
- Specificity of candidate biomarker p16 [Time frame: 1 day]
- Specificity of candidate biomarker NELL1 [Time frame: 1 day]
- Specificity of candidate biomarker AKAP12 [Time frame: 1 day]
- Specificity of candidate biomarker TAC1 [Time frame: 1 day]
- Specificity of candidate biomarker HPP1 [Time frame: 1 day]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 2 centers
- Bayview Medical Center — Baltimore
- Johns Hopkins Hospital — Baltimore
Identifiers
NCT: NCT04214119 · IRB00072332 · R01DK118250