EsoCheck + EsoGuard for Barrett's Esophagus and Esophageal Adenocarcinoma

(ESOGUARDBE2 Trial)

Recruiting at 34 trial locations

Overseen By Karyms Luna Miller

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Lucid Diagnostics, Inc.

Must be taking: Proton pump inhibitors

Must not be taking: Anti-coagulants

Disqualifiers: Esophageal varices, Dysphagia, Oropharyngeal tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

470 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses the EsoGuard test to detect esophageal diseases by analyzing cells collected with the EsoCheck device. It targets patients with Barrett's Esophagus and esophageal adenocarcinoma, as well as those undergoing screening. The test works by looking for specific DNA changes in the cells.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment EsoCheck + EsoGuard for Barrett's Esophagus and Esophageal Adenocarcinoma?

The research highlights the need for effective screening tools for Barrett's Esophagus and Esophageal Adenocarcinoma, as traditional methods like endoscopy have limitations. Innovations in screening, such as those being developed, aim to be more effective, minimally invasive, and accessible, which could potentially improve early detection and outcomes. ^{1 2 3 4 5}

Is EsoCheck + EsoGuard safe for humans?

The safety of esophagogastroduodenoscopy (EGD), a procedure related to EsoCheck and EsoGuard, has been studied in children, showing common symptoms like throat pain, chest pain, and difficulty swallowing after the procedure. Age and pre-existing symptoms can affect the likelihood of these side effects, but the number of biopsies taken does not increase risk. ^{6 7 8 9 10}

How is the treatment EsoCheck + EsoGuard for Barrett's Esophagus and Esophageal Adenocarcinoma different from other treatments?

EsoCheck + EsoGuard is unique because it offers a minimally invasive and more accessible screening option for Barrett's Esophagus and Esophageal Adenocarcinoma compared to the traditional esophagogastroduodenoscopy (EGD), which can be costly and less tolerable for patients. ^{3 11 12 13 14}

Research Team

Michelle McDermott

Principal Investigator

Lucid Diagnostics, Inc.

Eligibility Criteria

Inclusion Criteria

≥5 years either of Gastroesophageal Reflux Disease (GERD) symptoms, GERD treated with proton pump inhibitor (PPI) therapy (whether symptom control is achieved or not), or any combination of treated and untreated periods, as long the cumulative total is at least 5 years

All Patients:

Men aged 50 years and above

Exclusion Criteria

History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills

Oropharyngeal tumor

History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-In

Initial phase to derive optimal numerical cutoffs for EsoGuard assay using data from enrolled cases and controls

Up to 5 weeks

Efficacy

Phase to assess the sensitivity and specificity of the EsoGuard assay on esophageal cells collected using EsoCheck

Up to 5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• EsoCheck
• EsoGuard Assay
• Esophagogastroduodenoscopy

Participant Groups

Group I: EsoCheck and EsoGuard vs. EGD with or without biopsies Experimental Treatment 2 Interventions

All subjects will undergo both the EsoGuard lab assay run on distal esophageal cells collected with EsoCheck (non-invasive esophageal cell sample collection) device followed by Esophagogastroduodenoscopy (EGD) with or without biopsies

Who Is Running the Clinical Trial?

Lucid Diagnostics, Inc.

Lead Sponsor

Trials

7

Recruited

1,700+

References

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

The Annual Risk of Esophageal Adenocarcinoma Does Not Decrease Over Time in Patients With Barrett's Esophagus. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Pathogenesis and progression of oesophageal adenocarcinoma varies by prior diagnosis of Barrett's oesophagus. [2018]

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

Innovations in Screening Tools for Barrett's Esophagus and Esophageal Adenocarcinoma. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Surveillance endoscopy is associated with improved outcomes of oesophageal adenocarcinoma detected in patients with Barrett's oesophagus. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Critical appraisal of guidelines for screening and surveillance of Barrett's esophagus. [2020]

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

Pre-endoscopy Symptoms and Age, But Not Esophageal Biopsy Number Are Associated With Post-endoscopy Adverse Events. [2023]

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

Yield of Repeat Endoscopy for Barrett's Esophagus After Normal Index Endoscopy. [2023]

8. France pubmed.ncbi.nlm.nih.gov

Insufflation vs intubation during esophagogastroduodenoscopy in children. [2010]

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

Effect of a prior endoscopy on outcomes of esophageal adenocarcinoma among United States veterans. [2022]

10. Australia pubmed.ncbi.nlm.nih.gov

Postoperative bleeding risk after gastric endoscopic submucosal dissection during antithrombotic drug therapy. [2018]

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

Barrett esophagus and risk of esophageal cancer: a clinical review. [2022]

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

Clinical Outcomes of Endoscopic Submucosal Dissection for Adenocarcinoma of the Esophagogastric Junction. [2018]

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

Adenocarcinoma of the esophagogastric junction and Barrett's esophagus. [2019]

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

Risk factors for the development of esophageal adenocarcinoma in Barrett's esophagus. [2015]