Obese PatientsNCT06746623
Nonendoscopic Screening for Barrett's Esophagus in Veterans Without Chronic Reflux
A study testing Enrolled participants will complete Esocheck/Esoguard and diagnostic upper endoscopy. in people with Obese Patients and Tobacco Use, run by Louis Stokes VA Medical Center at 1 site in United States.
Trial summary
The veteran population is at increased risk for EAC and its precursor lesion, Barrett's esophagus (BE), due to increased prevalence of disease risk factors compared to the general population. BE is traditionally diagnosed only when patients undergo endoscopy with biopsies. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Obese Patients, Tobacco Use, Veterans
- What is being tested?
- Enrolled participants will complete Esocheck/Esoguard and diagnostic upper endoscopy.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients without history of chronic GERD who meet criteria for upper endoscopic screening for BE will be accrued35.
- Adults > 40 and < 85 years old who have no prior EGD and can provide informed consent
- Absence of chronic GERD symptoms (absence of weekly heartburn or regurgitation, not on medications for GERD), and are:
- Meet ACG/AGA Clinical Guideline criteria for BE screening. Eligible subjects will have at least three additional risk factors for BE (white race, obesity defined as BMI > 30, male gender, current smoker or smoking history > 10 pack years, family history of Barrett's esophagus or EAC central obesity (waist size > 35 inches for women and > 40 inches for men), white race, male sex, confirmed history of BE/EAC in at least two family members, with one a first degree relative).
- No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
- No significant dysphagia or odynophagia
Who cannot join
- History of prior EGD procedure in past ten years
- Inability to provide written informed consent
- History of weekly or more frequent heartburn or regurgitation for five or more years
- On anti-coagulant drug(s) that cannot be temporarily discontinued or coagulopathy with INR > 1.5
- 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
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- History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
- Oropharyngeal tumor
- History of esophageal or gastric surgery, with exception on uncomplicated recent surgical fundoplication procedure with documented normal acid exposure time (AET) percent (AET <4%)
- History of myocardial infarction or cerebrovascular accident within past 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Northeast Ohio Healthcare System
Cleveland, Ohio, 44106
Neal Associate Chief of Staff- Research, 216-791-3800 ext. x64661, neal.peachy@va.gov
About this study
Official title: Nonendoscopic Screening for Barrett's Esophagus and Esophageal Cancer in At-Risk Veterans Without History of Chronic Gastroesophageal Reflux
The veteran population is at increased risk for EAC and its precursor lesion, Barrett's esophagus (BE), due to increased prevalence of disease risk factors compared to the general population. BE is traditionally diagnosed only when patients undergo endoscopy with biopsies. However, due to the high cost of endoscopy and the lack of studies proving efficacy of screening, endoscopy to screen for BE is not routinely recommended. A simpler screening procedure similar to a pap smear would be an ideal way to sample the esophageal tissue for cancer and its precursor condition, BE. This study proposes a non-endoscopic detection method administered in outpatient offices which would increase subsequent endoscopic detection of BE. The study team will be enrolling veterans who do not have history of gastroesophageal reflux but have multiple risk factors for esophageal adenocarcinoma.
Read the detailed description
This research study addresses early detection of esophageal adenocarcinoma (EAC). Incidence of EAC has increased more than 6-fold in the past four decades yet prognosis for patients with EAC remains poor with less than 20% of patients surviving beyond 5 years. The veteran population is at increased risk for EAC and its precursor lesion, Barrett's esophagus (BE), due to increased prevalence of disease risk factors (age, male, obesity, smoking, family history of BE or EAC), compared to the general population. Current society guidelines recommend one-time upper endoscopy for persons with gastro-esophageal reflux (GERD) plus additional risk factors for BE and EAC. Still, up to 40% of patients who develop esophageal cancer do not report history of GERD preceding cancer diagnosis. Screening benefit needs to be explored in these patients without history of GERD.
Hypothesis: The incorporation of a non-endoscopic detection method in clinical practice will increase the positive predictive value of esophagogastroduodenoscopy (EGD) and increase the detection of BE among veterans who do not report GERD but have multiple risk factors for EAC.
Objectives: Unsedated non-endoscopic BE screening method will be offered to veterans at risk of EAC but without GERD history.
The Specific Aims are: 1. To detect BE in high-risk subjects without GERD, using a non-endoscopic biomarker-based screening tool. 2. Measure screening acceptance rate, reasons for refusal and screening yield.
Preliminary Data: Prospectively collected data from Cleveland VA showed that the sensitivity of this non-endoscopic screening tool in patients with chronic GERD and/or PPI use was 92.9% (95% CI 66.1-99.8), and specificity of 72.2% (95% CI 62.1-80.8). A retrospective study of 113 patients with EAC at Louis Stokes Cleveland VA Medical Center found that 52 (46%) presented with Stage IV disease. Of these patients with metastatic cancer who were eligible for screening, 20 (39%) had been seen in clinic at least one year prior to cancer diagnosis and had not been screened with EGD. In the overall group, 42 of the 117 patients had been seen in clinic with GERD previously and 26 (62%) had not been screened.
Research Design: Patients without history of GERD will be approached regarding BE screening. Reasons for refusal of screening will be recorded. Adult subjects without history of gastroesophageal reflux with three or more risk factors- white race, male gender, obesity (BMI > 30), smoking, or family history will be included. Only those patients who have not had prior EGD will be candidates for Esocheck screening. Distal esophageal samples will be assayed for mVIM + mCCNA1 (Esoguard assay). All patients will be asked to complete upper endoscopy.
Sample Size and Analysis: The prevalence of BE found on EGD performed in Caucasian men without chronic GERD is around 8.5%. Assuming prevalence of BE of 9%, and sensitivity/specificity of Esocheck/Esoguard equal to 90/90%, respectively, this study plans to recruit 400 patients. Sensitivity, specificity, diagnostic accuracy of Esocheck/Esoguard in patients without GERD will be calculated. Acceptance rates of screening will be reported. Latent class analysis will be performed to examine common patterns among patients who decline EAC screening.
- Conditions
- Obese Patients, Tobacco Use, Veterans, Family History of Esophageal Cancer, Barrett Esophagus
- Being tested
- Enrolled participants will complete Esocheck/Esoguard and diagnostic upper endoscopy.
- Keywords
- Non-endoscopic screening, esophagus, Barrett
- Medical subject headings
- Tobacco Use, Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enrolled participants will complete Esocheck/Esoguard and diagnostic upper endoscopy.Diagnostic test
Esocheck (EC)/Esoguard (EG): EC is a encapsulated balloon device available commercially from Lucid Diagnostics (New York, NY). EG assay uses bisulfite sequencing for detection of aberrant methylation in the vimentin and cyclin A1 genomic loci, respectively.
EGD (upper endoscopy): EGD will be performed by gastroenterologists practicing in the Louis Stokes Cleveland VA Medical Center Endoscopy laboratories on the same day when EC/EG is performed.
| Study group | Role | What they receive |
|---|---|---|
| This is a single arm study. Participants will complete 2 diagnostic tests: Esocheck and EGD. | Other | Patients without history of GERD receiving care in Wade Park VA will be approached regarding BE screening. Reasons for refusal of screening will be recorded. Adult subjects without history of gastroesophageal reflux with three or more risk factors- white race, male gender, obesity (BMI > 30), smoking, or family history will be included. Only those patients who have not had prior EGD will be candidates for Esocheck screening. Distal esophageal samples will be assayed for mVIM + mCCNA1 (Esoguard assay). All patients will be offered upper endoscopy. Receives: Diagnostic Test: Enrolled participants will complete Esocheck/Esoguard and diagnostic upper endoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esoguard assay and histology confirming diagnosis of Barrett's esophagus and/or esophageal adenocarcinoma
Results from enrollment visit
Measured: Laboratory and pathology results will be finalized within 10 and up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start11 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obese PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louis Stokes VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Katarina Greer, Louis Stokes VA Medical Center
- Investigators
- Katarina B Greer, MD/MS, Principal investigator, Cleveland VA Research and Education Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746623
- Sponsor's protocol ID
- DOD HT94252410741
- Status last verified
- Apr 2025
- First submitted
- 15 Nov 2024
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
Greer KB, Blum AE, Faulx AL, Deming EM, Hricik LL, Siddiqui H, Wilson BM, Chak A. Nonendoscopic Screening for Barrett's Esophagus and Esophageal Adenocarcinoma in At-Risk Veterans. Am J Gastroenterol. 2025 Mar 1;120(3):545-553. doi: 10.14309/ajg.0000000000002962. Epub 2024 Jul 11.
PubMed 38989889
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonendoscopic Screening for Barrett's Esophagus and Esophageal Cancer in At-Risk Veterans Without History of Chronic Gastroesophageal Reflux
- ClinicalTrials.gov ID
- NCT06746623
- Acronym / sponsor ID
- DOD HT94252410741
- Conditions
- Obese Patients, Tobacco Use, Veterans, Family History of Esophageal Cancer, Barrett Esophagus
- Keywords
- Non-endoscopic screening, esophagus, Barrett
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Louis Stokes VA Medical CenterUS federal agency
- Collaborators
- United States Department of Defense
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The veteran population is at increased risk for EAC and its precursor lesion, Barrett's esophagus (BE), due to increased prevalence of disease risk factors compared to the general population. BE is traditionally diagnosed only when patients undergo endoscopy with biopsies. However, due to the high cost of endoscopy and the lack of studies proving efficacy of screening, endoscopy to screen for BE is not routinely recommended. A simpler screening procedure similar to a pap smear would be an ideal way to sample the esophageal tissue for cancer and its precursor condition, BE. This study proposes a non-endoscopic detection method administered in outpatient offices which would increase subsequent endoscopic detection of BE. The study team will be enrolling veterans who do not have history of gastroesophageal reflux but have multiple risk factors for esophageal adenocarcinoma.
Detailed description
This research study addresses early detection of esophageal adenocarcinoma (EAC). Incidence of EAC has increased more than 6-fold in the past four decades yet prognosis for patients with EAC remains poor with less than 20% of patients surviving beyond 5 years. The veteran population is at increased risk for EAC and its precursor lesion, Barrett's esophagus (BE), due to increased prevalence of disease risk factors (age, male, obesity, smoking, family history of BE or EAC), compared to the general population. Current society guidelines recommend one-time upper endoscopy for persons with gastro-esophageal reflux (GERD) plus additional risk factors for BE and EAC. Still, up to 40% of patients who develop esophageal cancer do not report history of GERD preceding cancer diagnosis. Screening benefit needs to be explored in these patients without history of GERD.
Hypothesis: The incorporation of a non-endoscopic detection method in clinical practice will increase the positive predictive value of esophagogastroduodenoscopy (EGD) and increase the detection of BE among veterans who do not report GERD but have multiple risk factors for EAC.
Objectives: Unsedated non-endoscopic BE screening method will be offered to veterans at risk of EAC but without GERD history.
The Specific Aims are: 1. To detect BE in high-risk subjects without GERD, using a non-endoscopic biomarker-based screening tool. 2. Measure screening acceptance rate, reasons for refusal and screening yield.
Preliminary Data: Prospectively collected data from Cleveland VA showed that the sensitivity of this non-endoscopic screening tool in patients with chronic GERD and/or PPI use was 92.9% (95% CI 66.1-99.8), and specificity of 72.2% (95% CI 62.1-80.8). A retrospective study of 113 patients with EAC at Louis Stokes Cleveland VA Medical Center found that 52 (46%) presented with Stage IV disease. Of these patients with metastatic cancer who were eligible for screening, 20 (39%) had been seen in clinic at least one year prior to cancer diagnosis and had not been screened with EGD. In the overall group, 42 of the 117 patients had been seen in clinic with GERD previously and 26 (62%) had not been screened.
Research Design: Patients without history of GERD will be approached regarding BE screening. Reasons for refusal of screening will be recorded. Adult subjects without history of gastroesophageal reflux with three or more risk factors- white race, male gender, obesity (BMI > 30), smoking, or family history will be included. Only those patients who have not had prior EGD will be candidates for Esocheck screening. Distal esophageal samples will be assayed for mVIM + mCCNA1 (Esoguard assay). All patients will be asked to complete upper endoscopy.
Sample Size and Analysis: The prevalence of BE found on EGD performed in Caucasian men without chronic GERD is around 8.5%. Assuming prevalence of BE of 9%, and sensitivity/specificity of Esocheck/Esoguard equal to 90/90%, respectively, this study plans to recruit 400 patients. Sensitivity, specificity, diagnostic accuracy of Esocheck/Esoguard in patients without GERD will be calculated. Acceptance rates of screening will be reported. Latent class analysis will be performed to examine common patterns among patients who decline EAC screening.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| This is a single arm study. Participants will complete 2 diagnostic tests: Esocheck and EGD. | Other | Diagnostic Test: Enrolled participants will complete Esocheck/Esoguard and diagnostic upper endoscopy.Patients without history of GERD receiving care in Wade Park VA will be approached regarding BE screening. Reasons for refusal of screening will be recorded. Adult subjects without history of gastroesophageal reflux with three or more risk factors- white race, male gender, obesity (BMI > 30), smoking, or family history will be included. Only those patients who have not had prior EGD will be candidates for Esocheck screening. Distal esophageal samples will be assayed for mVIM + mCCNA1 (Esoguard assay). All patients will be offered upper endoscopy. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients without history of chronic GERD who meet criteria for upper endoscopic screening for BE will be accrued35.
Key exclusion criteria (10 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enrolled participants will complete Esocheck/Esoguard and diagnostic upper endoscopy.Esocheck (EC)/Esoguard (EG): EC is a encapsulated balloon device available commercially from Lucid Diagnostics (New York, NY). EG assay uses bisulfite sequencing for detection of aberrant methylation in the vimentin and cyclin A1 genomic loci, respectively. EGD (upper endoscopy): EGD will be performed by gastroenterologists practicing in the Louis Stokes Cleveland VA Medical Center Endoscopy laboratories on the same day when EC/EG is performed. | Diagnostic test | This is a single arm study. Participants will complete 2 diagnostic tests: Esocheck and EGD. |
Primary outcome
Esoguard assay and histology confirming diagnosis of Barrett's esophagus and/or esophageal adenocarcinoma
Time frame: Laboratory and pathology results will be finalized within 10 and up to 30 days
Results from enrollment visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Background: PubMed 38989889Greer KB, Blum AE, Faulx AL, Deming EM, Hricik LL, Siddiqui H, Wilson BM, Chak A. Nonendoscopic Screening for Barrett's Esophagus and Esophageal Adenocarcinoma in At-Risk Veterans. Am J Gastroenterol. 2025 Mar 1;120(3):545-553. doi: 10.14309/ajg.0000000000002962. Epub 2024 Jul 11.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katarina B Greer, MD/MS principal investigator
Cleveland VA Research and Education Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enrolled participants will complete Esocheck/Esoguard and diagnostic upper endoscopy. in people with Obese Patients and Tobacco Use, run by Louis Stokes VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katarina B. Greer, MD/MS (216-791-3800 ext. 61024, katarina.greer@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esoguard assay and histology confirming diagnosis of Barrett's esophagus and/or esophageal adenocarcinoma (time frame: Laboratory and pathology results will be finalized within 10 and up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06746623, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.