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Trial Title:
The Microbiome, Bile Acids, and Notch in Barrett's Esophagus (BE)
NCT ID:
NCT05524844
Condition:
Barrett Esophagus
Esophageal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Barrett Esophagus
Esophageal Neoplasms
Conditions: Keywords:
Saliva
Microbiome
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Sample Collection
Description:
Saliva, gastric aspirate, and esophageal brushings and biopsies.
Arm group label:
Barrett's Esophagus
Arm group label:
Control
Intervention type:
Other
Intervention name:
Endoscopy results
Description:
Results from standard of care endoscopy (scheduled separate of study)
Arm group label:
Barrett's Esophagus
Arm group label:
Control
Intervention type:
Other
Intervention name:
Dietary questionnaire
Description:
Diet History Questionnaire (II)
Arm group label:
Barrett's Esophagus
Arm group label:
Control
Summary:
The purpose of this study is to prospectively collect and analyze clinical data and
biospecimens from a cohort of 100 patients without BE (20), with non-dysplastic BE (40),
or with BE and high grade dysplasia (HGD) or EAC (40). The investigators will enroll 80
patients scheduled for upper endoscopy for clinical purposes, with a history of
histologically confirmed BE (2 cm length); 40 with no history of dysplasia, and 40 with
HGD or EAC. The investigators will also enroll 20 non-BE controls undergoing endoscopy
for any indication who are on stable dose proton-pump inhibitors (PPI) for the past
month. PPI therapy is standard of care for BE patients.
Detailed description:
The incidence of esophageal adenocarcinoma (EAC) has risen 10-fold over the past half
century and continues to have a dismal prognosis. Known risk factors for EAC do not
adequately explain these incidence trends; the rise in EAC cases began a decade before
increases in the prevalence of both gastro-esophageal reflux disease and obesity. Over
the past 50+ years, dramatic changes in the bacterial composition (or microbiome) of the
upper gastrointestinal tract have also occurred. While prior work has shown correlations
between the microbiome, BE, and EAC, there is a critical knowledge gap on mechanisms by
which bacteria interact with the esophagus and potentially promote cancer. The
investigators hypothesize that increased levels of the certain bile acids in
gastroesophageal reflux fluid cause changes that lead to increased interaction between
bacteria and the esophagus, which may promote the development of esophageal
adenocarcinoma (EAC). The investigators will carry out a case-control study of patients
with and without BE, dysplasia, or EAC. The investigators will focus on deoxycholic acid
in gastro-esophageal refluxate and its association with Notch signaling in tissue and
bacterial composition. The microbiome represents a novel and potentially modifiable risk
factor for the development of BE and EAC. Elucidation of microbiome features and
mechanisms that promote the development of EAC is a critical step that will lead to
subsequent trials of antibiotics, probiotics, and other interventions targeted to
altering the microbiome, with the goal of lowering the risk of this highly lethal
malignancy.
Criteria for eligibility:
Study pop:
Study population will be based on the population of BE and EAC as well as the
demographics of those who undergo upper endoscopy for other indications (the control
population) at Columbia and Cornell, together with data drawn from numerous prior studies
in our BE population.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
All subjects:
- Scheduled for an upper endoscopy
- Taking stable dose of a proton pump inhibitor at least once daily for 1 months prior
to enrollment
- Eighteen years of age or older
- Able to give informed consent
Barrett's esophagus subjects only:
- Histologically confirmed BE (defined as endoscopically- suspected BE with intestinal
metaplasia with goblet cells on esophageal biopsies)
- Maximal BE length ≥ 2 cm (Prague criteria: any C, M≥2)
Exclusion Criteria:
All subjects:
- History of head and neck cancer or esophageal or gastric cancer (except esophageal
intramucosal adenocarcinoma)
- History of esophageal or gastric surgery
- Use of antibiotics or immunosuppressants within 1 month prior to endoscopy
Barrett's esophagus subjects only:
• History of prior endoscopic therapy for BE, except a history of prior endoscopic
mucosal resection (EMR) of focal lesions withoutsubsequent ablative therapy is permitted
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Columbia University Irving Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Julian Abrams, MD
Phone:
212-305-1909
Email:
ja660@cumc.columbia.edu
Facility:
Name:
Weill Cornell Medical Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Felice Schnoll-Sussman, MD
Phone:
646-962-4463
Email:
fhs2001@med.cornell.edu
Start date:
February 9, 2021
Completion date:
December 2025
Lead sponsor:
Agency:
Columbia University
Agency class:
Other
Collaborator:
Agency:
Weill Medical College of Cornell University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Columbia University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05524844
