Clinical trial NCT04214119: EsophaCap for the Detection of Early Esophageal Carcinoma
Official title: EsophaCap for the Detection of Early Esophageal Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Barrett Esophagus
Esophageal Cancer
Gastric Cancer
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-01-02
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for clinically indicated upper endoscopy will be approached to participate in this study.

Brief 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.

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.

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

Primary outcomes:
measure: Difference in methylation of gene markers to discriminate Barrett's esophagus from non-pathological esophageal squamous and gastric cardia tissue.
timeFrame: 1 day
measure: Difference in methylation of gene markers to discriminate esophageal carcinoma from non-pathological esophageal squamous and gastric cardia tissue.
timeFrame: 1 day
measure: Difference in methylation of gene markers to discriminate gastric cancer from non-pathological esophageal squamous and gastric cardia tissue.
timeFrame: 1 day
Secondary outcomes:
measure: Sensitivity of candidate biomarker p16
timeFrame: 1 day
measure: Sensitivity of candidate biomarker NELL1
timeFrame: 1 day
measure: Sensitivity of candidate biomarker AKAP12
timeFrame: 1 day
measure: Sensitivity of candidate biomarker TAC1
timeFrame: 1 day
measure: Sensitivity of candidate biomarker HPP1
timeFrame: 1 day
measure: Specificity of candidate biomarker p16
timeFrame: 1 day
measure: Specificity of candidate biomarker NELL1
timeFrame: 1 day
measure: Specificity of candidate biomarker AKAP12
timeFrame: 1 day
measure: Specificity of candidate biomarker TAC1
timeFrame: 1 day
measure: Specificity of candidate biomarker HPP1
timeFrame: 1 day
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Stephen Meltzer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: