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

Status unconfirmed · Not applicable

Conditions studied: Barrett Esophagus, Esophageal Adenocarcinoma, Barretts Esophagus With Dysplasia, Barrett's Esophagus Without Dysplasia

In brief

The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay (lab developed test) on cells collected using the EsoCheck (501k cleared device) to detect Barrett's Esophagus (BE), with or without dysplasia, and esophageal adenocarcinoma (EAC) as compared to Esophagogastroduodenoscopy (EGD) plus biopsies in both confirmed cases of BE/EAC and in controls (subjects without a prior diagnosis but undergoing screening for BE/EAC)

Key facts

Study ID

NCT04295811

Run by

Lucid Diagnostics, Inc.

People needed

470

Starts

2020-06-18

Expected to finish

2023-12-01

Last updated by the study team

2023-01-25

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• All Patients:
• Men aged 50 years and above
• ≥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
• No solid foods eaten for at least 2 hours prior to EsoCheck procedure
• 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:
• Previous diagnosis of non-dysplastic Barrett's Esophagus (NDBE), low grade dysplasia (LGD), high grade dysplasia (HGD), and/or intramucosal adenocarcinoma (IMC)
• Diagnosis by esophagogastroduodenoscopy (EGD) (with exception of NDBE) was within 4 months prior to study enrollment
• Indicated for surveillance EGD or for therapeutic EGD
• Able to provide, by day of study EGD, the original glass slide(s) of biopsy specimens from most recent prior EGD

You may not qualify if…

• Inability to provide written informed consent
• On anti-coagulant drug(s) that cannot be temporarily discontinued
• Known history of esophageal varices or esophageal stricture
• 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
• 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
• History of myocardial infarction or cerebrovascular accident within past 6 months
• Any known lesion which, in the opinion of the endoscopist, obstructs greater than 25% of the esophageal lumen
• Prior participation in PR-0139/EG-CL-101 (Lucid BE Screening Study)
• 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
• History of esophageal motility disorder
• Currently implanted Linx device

Where it is running

• Lucid Investigative Site — Birmingham, Alabama, United States (enrolling)
• Lucid Investigative Site — Orange, California, United States (enrolling)
• Lucid Investigative Site — Aurora, Colorado, United States (enrolling)
• Lucid Investigative Site — Englewood, Colorado, United States (enrolling)
• Lucid Investigative Site — Washington D.C., District of Columbia, United States (enrolling)
• Lucid Investigative Site — Salt Lake City, Utah, United States (enrolling)
• Lucid Investigative Site — Richmond, Virginia, United States (enrolling)
• Lucid Investigative Site — Richmond, Virginia, United States (enrolling)
• Lucid Investigative Site — Amsterdam, Netherlands (enrolling)
• Lucid Investigative Site — Eindhoven, Netherlands (enrolling)
• Lucid Investigative Site — Groningen, Netherlands (enrolling)
• Lucid Investigative Site — Nieuwegein, Netherlands (enrolling)
• Lucid Investigative Site — Nijmegen, Netherlands (enrolling)
• Lucid Investigative Site — Rotterdam, Netherlands (enrolling)
• Lucid Investigative Site — Shreveport, Louisiana, United States (enrolling)
• Lucid Investigative Site — Baltimore, Maryland, United States (enrolling)
• Lucid Investigative Site — Boston, Massachusetts, United States (enrolling)
• Lucid Investigative Site — Ann Arbor, Michigan, United States (enrolling)
• Lucid Investigative Site — Flowood, Mississippi, United States (enrolling)
• Lucid Investigative Site — Omaha, Nebraska, United States (enrolling)
• Lucid Investigative Site — New Hyde Park, New York, United States (enrolling)
• Lucid Investigative Site — Chapel Hill, North Carolina, United States (enrolling)
• Lucid Investigative Site — Philadelphia, Pennsylvania, United States (enrolling)
• Lucid Investigative Site — Charleston, South Carolina, United States (enrolling)
• Lucid Investigative Site — Greenville, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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