Efficacy of EsoGuard Assay on Esophageal Surface Cells Collected With EsoCheck vs EGD for the Diagnosis of BE or EAC

Launched by LUCID DIAGNOSTICS, INC. · Mar 2, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new way to diagnose Barrett's Esophagus (BE) and esophageal adenocarcinoma (EAC) using a test called the EsoGuard assay. This test analyzes cells collected from the esophagus using a device called EsoCheck. Researchers want to see how well this method works compared to the traditional approach, which involves a procedure called esophagogastroduodenoscopy (EGD) that includes taking tissue samples. The trial aims to help identify patients with BE or EAC more effectively, particularly in those who might not have been diagnosed yet.

To participate in this study, men aged 50 and older who have experienced symptoms of acid reflux for at least five years may be eligible. Other factors that could qualify someone include having a family history of BE or EAC, being overweight, or having a history of smoking. Participants will undergo the EsoCheck procedure, and those with a previous diagnosis of BE or EAC will also have an EGD. If you or a loved one meet these criteria and are interested in learning more about this study, it could provide a new option for understanding esophageal health.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• All Patients:
• • 1. Men aged 50 years and above
• • 2. ≥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
• • 3. No solid foods eaten for at least 2 hours prior to EsoCheck procedure
• 4. One or more of the following:
• • Caucasian race
• • Current or past history of cigarette smoking
• • Body mass index (BMI) of at least 30 kg/m2
• • First-degree relative with Barrett's Esophagus (BE) or Esophageal Adenocarcinoma (EAC)
• Cases:
• • 1. Previous diagnosis of non-dysplastic Barrett's Esophagus (NDBE), low grade dysplasia (LGD), high grade dysplasia (HGD), and/or intramucosal adenocarcinoma (IMC)
• • 2. Diagnosis by esophagogastroduodenoscopy (EGD) (with exception of NDBE) was within 4 months prior to study enrollment
• • 3. Indicated for surveillance EGD or for therapeutic EGD
• • 4. Able to provide, by day of study EGD, the original glass slide(s) of biopsy specimens from most recent prior EGD
• Exclusion Criteria:
• • 1. Inability to provide written informed consent
• • 2. On anti-coagulant drug(s) that cannot be temporarily discontinued
• • 3. Known history of esophageal varices or esophageal stricture
• • 4. Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula, and/or esophageal ulceration
• • 5. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
• • 6. Oropharyngeal tumor
• • 7. History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure
• • 8. History of myocardial infarction or cerebrovascular accident within past 6 months
• • 9. Any known lesion which, in the opinion of the endoscopist, obstructs greater than 25% of the esophageal lumen
• • 10. Prior participation in PR-0139/EG-CL-101 (Lucid BE Screening Study)
• • 11. Prior EGD during which a therapeutic procedure such as, but not limited to, ablation, cryotherapy or endoscopic mucosal resection, was performed for the treatment of BE and/or EAC
• • 12. History of esophageal motility disorder
• • 13. Currently implanted Linx device