Diagnostic Tests for Detecting Barrett's Esophagus

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Amitabh Chak, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Case Comprehensive Cancer Center

Must not be taking: Anticoagulants

Disqualifiers: Esophageal varices, Dysphagia, Oropharyngeal tumor, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to develop a method to detect Barrett's esophagus (BE) in individuals with a new office-based diagnostic test.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on anti-coagulant drugs that cannot be temporarily stopped, you may not be eligible to participate.

Is the diagnostic test for Barrett's Esophagus safe?

Esophagogastroduodenoscopy (EGD), a procedure used to diagnose Barrett's Esophagus, is generally very safe with a low risk of serious complications like perforation or cardiopulmonary issues. However, there can be minor risks, especially in patients who are sick or sedated.

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How is the EsoCheck/EsoGuard treatment different from other treatments for Barrett's Esophagus?

EsoCheck/EsoGuard is unique because it combines a non-invasive cell collection device (EsoCheck) with a DNA test (EsoGuard) to detect Barrett's Esophagus, offering a less invasive alternative to traditional endoscopy, which requires inserting a tube through the mouth to examine the esophagus.

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Eligibility Criteria

This trial is for individuals over 50 with no chronic GERD, who have two risk factors for Barrett's Esophagus such as being white, having central obesity, male gender, smoking history or a family history of the condition. They must not have swallowing difficulties or blood clotting issues.

Inclusion Criteria

I am over 50 and have at least two risk factors for Barrett's esophagus.

I haven't had chronic heartburn or acid reflux for 5+ years.

I am over 50 and have at least two risk factors for Barrett's esophagus.

Exclusion Criteria

Inability to provide written informed consent

I don't have health issues that prevent me from undergoing specific esophageal exams or biopsies.

I have experienced heartburn or regurgitation weekly for over five years.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Testing

Participants complete a study questionnaire and undergo the EsoCheck/EsoGuard procedure to detect Barrett's esophagus

Up to 2 months

1 visit (in-person)

Endoscopy

Participants with positive EsoGuard results undergo standard of care upper endoscopy; selected negative participants may also undergo research EGD

Up to 2 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after diagnostic procedures

4 weeks

Participant Groups

The study aims to test a new office-based diagnostic method called EsoCheck/EsoGuard (EC/EG) against the standard Esophago-gastro-duodenoscopy (EGD) procedure in detecting Barrett's Esophagus in patients without typical GERD symptoms.

Group I: EC/EG & EGD Experimental Treatment 2 Interventions

Participants will complete a study questionnaire about reflux symptoms. Performance of an EsoCheck (EC) procedure; the EC sample will subsequently be tested with the EsoGuard (EG) assay If EG assay results come back positive, participant is requested to complete standard of care (SOC) upper endoscopy (tissue samples collected) If EG assay results come back negative, selected participants (100 volunteers) will also undergo a research EGD if they consent

EsoCheck/EsoGuard (EC/EG) is already approved in United States for the following indications:

🇺🇸 Approved in United States as EsoCheck/EsoGuard for:

• Detection of Barrett's Esophagus
• Esophageal Precancer Screening

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland, OH

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland, OH

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

The role of esophagogastroduodenoscopy in the diagnosis and management of upper gastrointestinal disorders. [2019] Esophagogastroduodenoscopy has revolutionized the clinical management of upper gastrointestinal diseases. Millions of EGDs are performed annually in the United States for many indications, such as gastrointestinal bleeding, abdominal pain, dysphagia, or surveillance of premalignant lesions. Esophagogastroduodenoscopy is very safe, with a low risk of serious complications such as perforation, cardiopulmonary arrest, or aspiration pneumonia. It is a highly sensitive and specific diagnostic test, especially when combined with endoscopic biopsy. Esophagogastroduodenoscopy is increasingly being used therapeutically to avoid surgery. New endoscopic technology such as endosonography, endoscopic sewing, and the endoscopic videocapsule will undoubtedly extend the frontiers and increase the indications for endoscopy.

2. Italy pubmed.ncbi.nlm.nih.gov

Lumevis ™: a new medical device to prepare patients for esophagogastroduodenoscopy. Experimental clinical study. [2021] Esophagogastroduodenoscopy (EGDS) is the gold standard exam for upper gastrointestinal diseases. EGDS is very important in Early Gastric Cancer diagnosis and treatment but it is an operator-dependent exam and there are lots of factors that reduce its visibility (mucus, bubbles and foam).

3. United States pubmed.ncbi.nlm.nih.gov

Recent advances in diagnostic upper endoscopy. [2020] Esophageo-gastro-duodenoscopy (EGD) is an important procedure used for detection and diagnosis of esophago-gastric lesions. There exists no consensus on the technique of examination.

4. Germany pubmed.ncbi.nlm.nih.gov

A randomized trial of unsedated transnasal small-caliber esophagogastroduodenoscopy (EGD) versus peroral small-caliber EGD versus conventional EGD. [2022] Unsedated esophagogastroduodenoscopy (EGD) has advantages over sedated EGD - e. g., prevention of side effects related to sedation, less patient monitoring, and less expense. This study compared the feasibility and tolerance of transnasal small-caliber (TSC-EGD) and peroral small-caliber EGD (PSC-EGD) with conventional EGD (C-EGD).

5. India pubmed.ncbi.nlm.nih.gov

Electrocardiographic changes during oesophagogastroscopy. [2013] Oesophagogastroduodenoscopy (EGD) should be very safe, but there are many potential hazards, although the rate of serious complications is small. There are so many complications that can arise during this procedure. Most of these complications involve the respiratory or cardiovascular systems, especially in sick or sedated patients.The aim of this study was to determine the various electrocardiographic changes that can occur at different stages of diagnostic EGD and to determine their severity.

6. United States pubmed.ncbi.nlm.nih.gov

Acceptability, Accuracy, and Safety of Disposable Transnasal Capsule Endoscopy for Barrett's Esophagus Screening. [2021] Screening for Barrett's esophagus (BE) with conventional esophagogastroduodenoscopy (C-EGD) is expensive. We assessed the performance of a clinic-based, single use transnasal capsule endoscope (EG Scan II) for the detection of BE, compared to C-EGD as the reference standard.

7. United States pubmed.ncbi.nlm.nih.gov

Blinded comparison of esophageal capsule endoscopy versus conventional endoscopy for a diagnosis of Barrett's esophagus in patients with chronic gastroesophageal reflux. [2023] Esophageal capsule endoscopy (ECE) is an alternative to EGD for Barrett's esophagus screening. A multicenter study found ECE to be safe, well tolerated, and accurate; however, a post hoc adjudication process was used that may have biased results.

8. United States pubmed.ncbi.nlm.nih.gov

Diagnostic inconsistencies in Barrett's esophagus. Department of Veterans Affairs Gastroesophageal Reflux Study Group. [2016] Few studies have compared the precision of various diagnostic tests used to determine the presence of Barrett's esophagus. The aim of this study was to compare the results of histological, endoscopic, and manometric tests for patients with Barrett's esophagus in two closely spaced examinations.