Principal Investigator: John Fang
Keywords: EsoGuard , EsoCheck , EGD , Barrett's Esophagus , Esophageal Adenocarcinoma , Esophagogastroduedonoscopy Alternative Department: Gastroenterology
IRB Number: 00131631
Specialty: Gastroenterology, Gastroenterology, Gastroenterology, Gastroenterology
Sub Specialties: Esophageal Diseases, Barrett's Esophagus, Endoscopy
Recruitment Status: Recruiting

Contact Information

Brinnlie Harward
brinnlie.harward@hsc.utah.edu
8015879050

Brief Summary

Lucid Diagnostics, Inc., is developing a novel diagnostic system as a screening tool for Barrett’s Esophagus (BE) consisting of two devices, EsoCheck, a non-invasive cell collection device designed to sample cells from a targeted region of the esophagus, and EsoGuard, an assay which examines for the presence of cytosine methylation at 31 different genomic locations on the VIM and CCNA1 genes. The combined system may offer an accurate, lower cost, non-invasive, approach to screen for BE with and without dysplasia, and for esophageal adenocarcinoma (EAC), as compared with the current gold standard, namely diagnostic esophagogastroduodenoscopy (EGD) plus biopsy.

The main study phase is a two-phase Case-Control study. A Run-In phase will be conducted in order to derive numerical cutoffs for mVIM and mCCNA1 scoring as inputs into an algorithm used to determine a positive versus negative EsoGuard result in order to optimize assay sensitivity and specificity for its intended use as a screening test in the at-risk population. The assay, once validated and locked, will be used to analyze patient biospecimens obtained in both the Efficacy phase of this Case Control study as well as in a separate Screening study to be conducted in parallel. The Efficacy phase is intended to estimate the sensitivity of EsoGuard, on samples collected using EsoCheck, to diagnose each of four subgroups of BE, including non-dysplastic BE (NDBE), BE with low grade dysplasia (LGD), BE with high grade dysplasia (HGD), and EAC (specifically esophageal intramucosal adenocarcinoma [IMC]) in a population of known Cases, independently against prespecified performance goals. Specificity will be estimated in a group of concurrent Controls confirmed to be free of these conditions.

The objective of the Run-in Phase is to derive numerical cutoffs for mVIM and mCCNA1 scoring as inputs into an algorithm used to determine a positive versus negative EsoGuard result, in order to optimize assay sensitivity and specificity for its intended use as a screening test in the at-risk population. The assay, once validated and locked, will be used to analyze patient biospecimens obtained in both the Efficacy phase of this Case Control study as well as in a separate Screening study to be conducted in parallel.

Primary: The primary efficacy objectives of this study are to measure the sensitivities of EsoGuard-based diagnosis in 54 cases each of NDBE, LGD, HGD, and adenocarcinoma, either intramucosal or submucosally invasive (IMC/EAC) in order to assess EsoGuard’s ability to detect disease across the entire continuum of disease progression.

Secondary: The Secondary efficacy objective is to quantify the specificity in 54 concurrent Controls without BE or IMC/EAC.

Inclusion Criteria

EsoCheck Device Administration Training Phase:

1. Males and Females age 22 and over

2. No solid foods eaten for at least 2 hours prior to EsoCheck procedure

Main Study Phase:

In order to be eligible to participate in this study, an individual must meet all of the criteria listed below for all patients. Patients enrolled as cases must also meet the additional criteria for Cases listed below.

1. Men aged 50 years and above 

2. ≥5 years either of

- 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 BE or EAC

Additional Inclusion Criteria for Cases:

1. Previous diagnosis of NDBE, LGD, HGD, and/or IMC

2. Previous diagnosis by EGD of NDBE at any time or previous diagnosis by EGD of LGD, HGD and/or IMC within 4 months prior to study enrollment

3. Indicated for surveillance EGD or for therapeutic EGD

4. Able to provide the original glass slide(s) of biopsy specimens from most recent prior EGD

 

Exclusion Criteria

EsoCheck Device Administration Training Phase:

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 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, whether physician diagnosed or patient reported, of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills or sensation of food being stuck in the throat or esophagus, and/or patient reported history of significant anxiety from, or difficulties with, tolerating dental procedures due to gagging

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 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.

11. History of esophageal motility disorder

12. Currently implanted Linx device

13. Prior participation in the training or main study phases of the EG-CL-101/EG-CL-102 studies, and/or the BETRNet study (NCT00288119).

Main Study Phase:

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, whether physician diagnosed or patient reported, of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills or sensation of food being stuck in the throat or esophagus, and/or significant anxiety from, or difficulty tolerating dental procedures due to gagging.

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