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Detection of Barrett s Esophagus in Patients Without GERD Symptoms

Primary Purpose

Barrett's Esophagus

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

EsoCheck/EsoGuard (EC/EG)

Esophago-gastro-duodenoscopy (EGD)

About this trial

This is an interventional screening trial for Barrett's Esophagus

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EC/EG & EGD

Arm Description

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

Outcomes

Primary Outcome Measures

Positive predictive value (PPV) of EC/EG in a non-GERD population that has three or more non-GERD risk factors for BE.

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))

Proportion of participants negative via EC/EG who subsequently are proven negative via EGD

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04880044

First Posted

May 5, 2021

Last Updated

August 16, 2023

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT04880044

Brief Title

Detection of Barrett s Esophagus in Patients Without GERD Symptoms

Official Title

Detection of Barrett s Esophagus in Patients Without Gastroesophageal Reflux Disease (GERD) Symptoms

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 5, 2022 (Actual)

Primary Completion Date

July 1, 2024 (Anticipated)

Study Completion Date

July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Barrett's Esophagus

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EC/EG & EGD

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

EsoCheck/EsoGuard (EC/EG)

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Esophago-gastro-duodenoscopy (EGD)

Intervention Description

SOC diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. Tissue samples collected.

Primary Outcome Measure Information:

Title

Positive predictive value (PPV) of EC/EG in a non-GERD population that has three or more non-GERD risk factors for BE.

Description

Time Frame

Up to 2 months

Title

Proportion of participants negative via EC/EG who subsequently are proven negative via EGD

Description

Time Frame

Up to 2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amitabh Chak, MD

Phone

1-800-641-2422

CTUReferral@UHhospitals.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amitabh Chak, MD

Organizational Affiliation

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106-5065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amitabh Chak, MD

Phone

800-641-2422

CTUReferral@UHhospitals.org

First Name & Middle Initial & Last Name & Degree

Amitabh Chak, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All individual participant data (IPD) that result in publication

Learn more about this trial

Detection of Barrett s Esophagus in Patients Without GERD Symptoms

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