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Diagnostic Test

Non-Endoscopic Esophageal Sampling for Barrett's Esophagus and Esophageal Cancer

N/A

Recruiting

Led By Katarina B Greer, MD/MS

Research Sponsored by Cleveland VA Medical Research and Education Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 2.5 years

Awards & highlights

Study Summary

This trial will test a new method for detecting Barrett's esophagus and esophageal cancer in primary care patients. The new method, called Esocheck/Esoguard, is non-endoscopic, meaning it does not require a scope be inserted down the throat. The trial will compare the new method's effectiveness to that of standard endoscopic screening.

Who is the study for?

This trial is for Veterans aged 40-85 with GERD symptoms, no prior upper endoscopies, and at least two additional risk factors for Barrett's Esophagus such as obesity or a smoking history. They must be able to consent and not have coagulopathy, esophageal varices, or significant swallowing pain.Check my eligibility

What is being tested?

The study tests Esocheck/Esoguard, non-endoscopic tools for detecting Barrett's Esophagus and esophageal cancer in primary care. It aims to see if these methods can improve the accuracy of endoscopy predictions and increase detection rates.See study design

What are the potential side effects?

While specific side effects are not detailed here, non-endoscopic procedures like Esocheck/Esoguard typically involve less discomfort than traditional scopes with minimal risks such as throat irritation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sensitivity and Specificity of Esocheck/Esoguard in a Veteran population

Secondary outcome measures

Cost of two screening strategies

Number/percentage of screened patients with diagnosis of Barrett's esophagus and/or esophageal adenocarcinoma

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients undergoing routine screening via upper endoscopy (EGD)Experimental Treatment1 Intervention

All enrolled patients will complete upper endoscopy for screening for Barrett's esophagus and esophageal adenocarcinoma.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED

863 Previous Clinical Trials

227,507 Total Patients Enrolled

Cleveland VA Medical Research and Education FoundationLead Sponsor

Katarina B Greer, MD/MSPrincipal InvestigatorLouis Stokes Cleveland VA Medical Center

Media Library

Esocheck/Esoguard (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT05210049 — N/A

Barrett's Esophagus Clinical Trial 2023: Esocheck/Esoguard Highlights & Side Effects. Trial Name: NCT05210049 — N/A

Esocheck/Esoguard (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05210049 — N/A

Barrett's Esophagus Research Study Groups: Patients undergoing routine screening via upper endoscopy (EGD)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to volunteer for this clinical experiment?

"Based on records presented by clinicaltrials.gov, this trial is not presently recruiting participants. This assessment was last updated on the 10th of January 2022, since its initial posting on February 1st 2022. Currently, there are 1380 other medical trials actively seeking candidates for enrollment around the world."

Answered by AI

Is participation in this trial open to octogenarians?

"The target population of this trial are individuals aged 40 or over and below 85 years old."

Answered by AI

To what extent do candidates qualify to participate in this clinical experiment?

"This clinical trial is looking to recruit 125 adults, aged 40-85, diagnosed with Barrett Esophagus. Furthermore, participants must be adult veterans that have not had an EGD procedure before and are willing to consent; they must also lack any known coagulopathy or esophageal varices as well as having no significant dysphagia or odynophagia. Additionally, the trial requires these persons experienced GERD for over 5 years plus at least two additional risk factors (such as white race, obesity defined by BMI > 30, male gender etc.)."

Answered by AI

Recent research and studies

EpigeneticsJournal

DNA Methylation Profiling in Barrett’s Esophagus and Esophageal Adenocarcinoma Reveals Unique Methylation Signatures and Molecular Subclasses

Kaz, Andrew M., Chao-Jen Wong, Yanxin Luo, Jeffrey B. Virgin, M. Kay Washington, Joseph E. Willis, Rom S. Leidner, Amitabh Chak, and William M. Grady. 2011. “DNA Methylation Profiling in Barrett’s Esophagus and Esophageal Adenocarcinoma Reveals Unique Methylation Signatures and Molecular Subclasses”. Epigenetics. Informa UK Limited. doi:10.4161/epi.6.12.18199.

Science Translational MedicineJournal

Identifying DNA Methylation Biomarkers for Non-endoscopic Detection of Barrett’s Esophagus

Moinova, Helen R., Thomas LaFramboise, James D. Lutterbaugh, Apoorva Krishna Chandar, John Dumot, Ashley Faulx, Wendy Brock, et al.. 2018. “Identifying DNA Methylation Biomarkers for Non-endoscopic Detection of Barrett’s Esophagus”. Science Translational Medicine. American Association for the Advancement of Science (AAAS). doi:10.1126/scitranslmed.aao5848.

Cancer Epidemiology, Biomarkers & PreventionJournal

Barrett's Esophagus and Esophageal Adenocarcinoma Biomarkers

Grady, William M., Ming Yu, Sanford D. Markowitz, and Amitabh Chak. 2020. “Barrett's Esophagus and Esophageal Adenocarcinoma Biomarkers”. Cancer Epidemiology, Biomarkers & Prevention. American Association for Cancer Research (AACR). doi:10.1158/1055-9965.epi-20-0223.

Gastrointestinal Endoscopy Clinics of North AmericaJournal