RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

A Multicenter Case-Control Study of the Efficacy of EsoGuard on Samples Collected Using EsoCheck, Versus Esophagogastroduodenoscopy, for the Diagnosis of Barrett's Esophagus With and Without Dysplasia, and for Esophageal Adenocarcinoma

Quick Facts

Study Start:2020-06-18
Study Completion:2023-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04295811

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Men aged 50 years and above
  2. 2. ≥5 years either of
  3. * Gastroesophageal Reflux Disease (GERD) symptoms,
  4. * GERD treated with proton pump inhibitor (PPI) therapy (whether symptom control is achieved or not), or
  5. * any combination of treated and untreated periods, as long the cumulative total is at least 5 years
  6. 3. No solid foods eaten for at least 2 hours prior to EsoCheck procedure
  7. 4. One or more of the following:
  8. * Caucasian race
  9. * Current or past history of cigarette smoking
  10. * Body mass index (BMI) of at least 30 kg/m2
  11. * First-degree relative with Barrett's Esophagus (BE) or Esophageal Adenocarcinoma (EAC)
  12. 1. Previous diagnosis of non-dysplastic Barrett's Esophagus (NDBE), low grade dysplasia (LGD), high grade dysplasia (HGD), and/or intramucosal adenocarcinoma (IMC)
  13. 2. Diagnosis by esophagogastroduodenoscopy (EGD) (with exception of NDBE) was within 4 months prior to study enrollment
  14. 3. Indicated for surveillance EGD or for therapeutic EGD
  15. 4. Able to provide, by day of study EGD, the original glass slide(s) of biopsy specimens from most recent prior EGD
  1. 1. Inability to provide written informed consent
  2. 2. On anti-coagulant drug(s) that cannot be temporarily discontinued
  3. 3. Known history of esophageal varices or esophageal stricture
  4. 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. 5. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
  6. 6. Oropharyngeal tumor
  7. 7. History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure
  8. 8. History of myocardial infarction or cerebrovascular accident within past 6 months
  9. 9. Any known lesion which, in the opinion of the endoscopist, obstructs greater than 25% of the esophageal lumen
  10. 10. Prior participation in PR-0139/EG-CL-101 (Lucid BE Screening Study)
  11. 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. 12. History of esophageal motility disorder
  13. 13. Currently implanted Linx device

Contacts and Locations

Study Contact

Alexa Rueda
CONTACT
9157405766
AXR@pavmed.com
Karyms Luna Miller
CONTACT
klm@pavmed.com

Principal Investigator

Michelle McDermott
STUDY_DIRECTOR
Lucid Diagnostics, Inc.

Study Locations (Sites)

Lucid Investigative Site
Birmingham, Alabama, 35294
United States
Lucid Investigative Site
Orange, California, 92868
United States
Lucid Investigative Site
Aurora, Colorado, 80045
United States
Lucid Investigative Site
Englewood, Colorado, 80113
United States
Lucid Investigative Site
Washington, District of Columbia, 20007
United States
Lucid Investigative Site
Jacksonville, Florida, 32256
United States
Lucid Investigative Site
Chicago, Illinois, 60611
United States
Lucid Investigative Site
Shreveport, Louisiana, 71105
United States
Lucid Investigative Site
Baltimore, Maryland, 21287
United States
Lucid Investigative Site
Boston, Massachusetts, 02215
United States
Lucid Investigative Site
Ann Arbor, Michigan, 48109
United States
Lucid Investigative Site
Flowood, Mississippi, 39232
United States
Lucid Investigative Site
Saint Louis, Missouri, 63110
United States
Lucid Investigative Site
Omaha, Nebraska, 68124
United States
Lucid Investigative Site
Lebanon, New Hampshire, 03756
United States
Lucid Investigative Site
New Hyde Park, New York, 11030
United States
Lucid Investigative Site
Rochester, New York, 14620
United States
Lucid Investigative Site
Chapel Hill, North Carolina, 27599
United States
Lucid Investigative Site
Portland, Oregon, 97239
United States
Lucid Investigative Site
Philadelphia, Pennsylvania, 19104
United States
Lucid Investigative Site
Philadelphia, Pennsylvania, 19107
United States
Lucid Investigative Site
Providence, Rhode Island, 02903
United States
Lucid Investigative Site
Charleston, South Carolina, 29425
United States
Lucid Investigative Site
Greenville, South Carolina, 29615
United States
Lucid Investigative Site
Knoxville, Tennessee, 37909
United States
Lucid Investigative Site
Nashville, Tennessee, 37212
United States
Lucid Investigative Site
Austin, Texas, 78712
United States
Lucid Investigative Site
Dallas, Texas, 75246
United States
Lucid Investigative Site
Houston, Texas, 77030
United States
Lucid Investigative Site
Salt Lake City, Utah, 84132
United States
Lucid Investigative Site
Richmond, Virginia, 23249
United States
Lucid Investigative Site
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Lucid Diagnostics, Inc.

  • Michelle McDermott, STUDY_DIRECTOR, Lucid Diagnostics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-06-18
Study Completion Date2023-12

Study Record Updates

Study Start Date2020-06-18
Study Completion Date2023-12

Terms related to this study

Additional Relevant MeSH Terms

  • Barrett Esophagus
  • Esophageal Adenocarcinoma
  • Barretts Esophagus With Dysplasia
  • Barrett's Esophagus Without Dysplasia