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Trial record 4 of 4 for:    esocheck

Detection of Barrett s Esophagus in Patients Without GERD Symptoms

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ClinicalTrials.gov Identifier: NCT04880044
Recruitment Status : Not yet recruiting
First Posted : May 10, 2021
Last Update Posted : September 9, 2021
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:
The purpose of this study is to develop a method to detect Barrett's esophagus (BE) in individuals with a new office-based diagnostic test.

Condition or disease Intervention/treatment Phase
Barrett's Esophagus Diagnostic Test: EsoCheck/EsoGuard (EC/EG) Diagnostic Test: Esophago-gastro-duodenoscopy (EGD) Not Applicable

Detailed Description:

This study will investigate whether using EsoCheck/EsoGuard(EC/EG) can detect BE in individuals at risk for BE who are currently not being detected and are not undergoing routine esophago-gastro-duodenoscopy (EGD)

BE can only be diagnosed by performing upper endoscopy. Up to 500 adults who have risk factors for BE but do not have chronic heartburn or regurgitation will be enrolled in this study. This will include the EsoCheck/EsoGuard determination along with the upper endoscopy for qualifying EsoGuard negative subjects

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Detection of Barrett s Esophagus in Patients Without Gastroesophageal Reflux Disease (GERD) Symptoms
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2025

Arm Intervention/treatment
Experimental: EC/EG & EGD

Participants will complete a study questionnaire about reflux symptoms. Performance of an EsoCheck (EC) procedure; the EC sample will subsequently be tested with the EsoGuard (EG) assay

If EG assay results come back positive, participant is requested to complete standard of care (SOC) upper endoscopy (tissue samples collected)

If EG assay results come back negative, selected participants (100 volunteers) will also undergo a research EGD if they consent

Diagnostic Test: EsoCheck/EsoGuard (EC/EG)
EC is a swallowed capsule on a tethered catheter that obtains a touch sample of the distal esophagus. The obtained sample is placed in a buffer and sent to a diagnostics lab for testing of methylated markers from extracted DNA. EG is a methylated DNA test . A positive EG is associated with Barrett's esophagus at all its stages.

Diagnostic Test: Esophago-gastro-duodenoscopy (EGD)
SOC diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. Tissue samples collected.




Primary Outcome Measures :
  1. Positive predictive value (PPV) of EC/EG in a non-GERD population that has three or more non-GERD risk factors for BE. [ Time Frame: Up to 2 months ]

    PPV of EC/EG in a non-GERD population that has three or more non-GERD risk factors for BE. Participants who are at risk will be offered EC/EG. Those who are positive will undergo subsequent EGD

    PPV = (EC/EG positive & EGD positive) / ((EC/EG positive & EGD positive) + (EC/EG positive & EGD negative))


  2. Proportion of participants negative via EC/EG who subsequently are proven negative via EGD [ Time Frame: Up to 2 months ]

    Negative Predictive Value (NPV):

    Proportion of participants negative via EC/EG who subsequently are proven negative via EGD. This will be measured by offering EGD to a proportion of patients who are EC/EG negative.




Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • No known coagulopathy, no known esophageal varices.
  • No significant dysphagia or odynophagia
  • Absence of chronic GERD, defined as five or more years of heartburn or regurgitation with symptoms at least once a week when not on medications for GERD symptoms.
  • Subjects to qualify must meet criterion 3, be over age 50, and have two additional risk factors for BE (white race, central obesity defined as waist size >35 inches for women and >40 inches for men, male gender, current smoker or smoking history >10 pack years, confirmed family history in at least two members with one being a first degree relative).

Exclusion Criteria:

  • History of prior EGD procedure
  • Inability to provide written informed consent
  • History of weekly of more frequent heartburn or regurgitation for five or more years
  • On anti-coagulant drug(s)that cannot be temporarily discontinued or coagulopathy with international normalized ratio (INR) > 1.5
  • Known history of esophageal varices or esophageal stricture
  • Any contraindication, as deemed inInvestigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGDprocedure,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 on uncomplicated surgical fundoplication procedure
  • History of myocardial infarction or cerebrovascular accident within past 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04880044


Contacts
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Contact: Amitabh Chak, MD 1-800-641-2422 CTUReferral@UHhospitals.org

Locations
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United States, Ohio
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Contact: Amitabh Chak, MD    800-641-2422    CTUReferral@UHhospitals.org   
Principal Investigator: Amitabh Chak, MD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Amitabh Chak, MD University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04880044    
Other Study ID Numbers: CASE1221
First Posted: May 10, 2021    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data (IPD) that result in publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases