EsophaCap for the Detection of Early Esophageal Carcinoma

Gastric Cancer Clinical Trial

Official title:

EsophaCap for the Detection of Early Esophageal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04214119
• Other study ID #: IRB00072332
• Secondary ID: R01DK118250
• Status: Recruiting
• Start date: January 12, 2016
• Est. completion date: December 19, 2025

Study information

• Verified date: January 2024
• Source: Johns Hopkins University
• Contact: Stephen J Meltzer, M.D.
• Phone: 4105026071
• Email: smeltzer[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 19, 2025
• Est. primary completion date: December 19, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer

Locations

Country	Name	City	State
United States	Bayview Medical Center	Baltimore	Maryland
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in methylation of gene markers to discriminate Barrett's esophagus from non-pathological esophageal squamous and gastric cardia tissue.	Using DNA methylation, we plan on identifying, from a pool of highly selected marker candidates, the best biomarkers that are aberrantly methylated in Barrett's esophagus versus control in order to differentiate between subjects who have Barrett's esophagus and those who do not have Barrett's esophagus. This is measure using methylation index and the calculated probability score from different methylation index values.	1 day
Primary	Difference in methylation of gene markers to discriminate esophageal carcinoma from non-pathological esophageal squamous and gastric cardia tissue.	Using DNA methylation, we plan on identifying, from a pool of highly selected marker candidates, the best biomarkers that are aberrantly methylated in esophageal cancer versus control in order to differentiate between subjects who have esophageal cancer and those who do not. This is measure using methylation index and the calculated probability score from different methylation index values.	1 day
Primary	Difference in methylation of gene markers to discriminate gastric cancer from non-pathological esophageal squamous and gastric cardia tissue.	Using DNA methylation, we plan on identifying, from a pool of highly selected marker candidates, the best biomarkers that are aberrantly methylated in gastric cancer versus control in order to differentiate between subjects who have gastric cancer and those who do not. This is measure using methylation index and the calculated probability score from different methylation index values.	1 day
Secondary	Sensitivity of candidate biomarker p16	Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.	1 day
Secondary	Sensitivity of candidate biomarker NELL1	Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.	1 day
Secondary	Sensitivity of candidate biomarker AKAP12	Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.	1 day
Secondary	Sensitivity of candidate biomarker TAC1	Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.	1 day
Secondary	Sensitivity of candidate biomarker HPP1	Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.	1 day
Secondary	Specificity of candidate biomarker p16	Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.	1 day
Secondary	Specificity of candidate biomarker NELL1	Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.	1 day
Secondary	Specificity of candidate biomarker AKAP12	Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.	1 day
Secondary	Specificity of candidate biomarker TAC1	Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.	1 day
Secondary	Specificity of candidate biomarker HPP1	Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.	1 day