Ignite Creation Date:
2024-05-06 @ 6:02 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05524844
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2022-08-30
Brief Title:
The Microbiome Bile Acids and Notch in Barretts Esophagus BE
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
The Role of the Microbiome and Notch Signaling in Esophageal Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA255298 | NIH | None | httpsreporternihgovquickSearchR01CA255298 |