RightFit
RecruitingNot applicable

Nonendoscopic Screening for Barrett's Esophagus in Veterans Without Chronic Reflux

Nonendoscopic Screening for Barrett's Esophagus and Esophageal Cancer in At-Risk Veterans Without History of Chronic Gastroesophageal Reflux

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "BE is traditionally diagnosed only when patients undergo endoscopy with biopsies."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a way to check for Barrett’s esophagus without using a camera tube called an endoscope. Barrett’s is a change in the lining of the food pipe that can lead to cancer. The study is for veterans without long-term acid reflux who have several risk factors for this cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 40 and younger than 85.
  • Have never had an upper endoscopy, a test using a camera tube to look inside the upper digestive tract.
  • Be able to understand the study and agree to take part.
  • Have no weekly heartburn or food or liquid coming back up, and take no acid reflux medicines.
  • Meet screening guidelines and have at least 3 added risk factors. Listed factors include being White, being male, a body mass index (BMI) over 30, current smoking or a smoking history over 10 pack-years, a large waist, and a family history of Barrett’s or this cancer. Ten pack-years means smoking 1 pack a day for 10 years.
  • The large-waist limits are over 35 inches for women and over 40 inches for men. The family history criteria also list at least 2 affected relatives, including a parent, sibling, or child.
  • Have no known blood-clotting disorder or swollen veins in the food pipe, and do not take blood thinners long term.
  • Have no major trouble swallowing or pain when swallowing.

Who can't join

  • Had an upper endoscopy in the past 10 years, or cannot give written consent to join.
  • Had heartburn or food or liquid coming back up at least weekly for 5 years or longer.
  • Take blood thinners that cannot be stopped for a short time, or have a clotting disorder with an INR blood test result over 1.5.
  • Have swollen veins or narrowing in the food pipe.
  • Have a condition that the study doctor thinks makes EsoCheck, endoscopy, or tissue sampling unsafe. Examples include a clotting disorder, pouches, abnormal openings, or sores in the food pipe.
  • Have trouble or pain when swallowing, including pills, or have a tumor in the back of the mouth or throat.
  • Had food pipe or stomach surgery. An exception may apply to recent, uncomplicated acid reflux surgery called fundoplication, with a recorded normal acid exposure time below 4%.
  • Had a heart attack or stroke in the past 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Patients without history of chronic GERD who meet criteria for upper endoscopic screening for BE will be accrued35. 1. Adults \> 40 and \< 85 years old who have no prior EGD and can provide informed consent 2. Absence of chronic GERD symptoms (absence of weekly heartburn or regurgitation, not on medications for GERD), and are: a. 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). 3. No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have: 4. No significant dysphagia or odynophagia Exclusion Criteria: * Exclusion Criteria 1. History of prior EGD procedure in past ten years 2. Inability to provide written informed consent 3. History of weekly or more frequent heartburn or regurgitation for five or more years 4. On anti-coagulant drug(s) that cannot be temporarily discontinued or coagulopathy with INR \> 1.5 5. Known history of esophageal varices or esophageal stricture 6. 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 7. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills 8. Oropharyngeal tumor 9. History of esophageal or gastric surgery, with exception on uncomplicated recent surgical fundoplication procedure with documented normal acid exposure time (AET) percent (AET \<4%) 10. History of myocardial infarction or cerebrovascular accident within past 6 months

Study sites (1)

OH