Clinical trial · Observational
Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus
NCT01281618CI-TRIAL-00010216CR20completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the association between acid reflux and cell changes in Barrett's esophagus. Specific aim 1: To test the hypothesis that controlled acid reflux is associated with lesser degree of stromal activation. Specific aim 2: To test the hypothesis that stromal fibroblast derived growth factors drive BE epithelial proliferation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 24 hour pH study and upper endoscopy (EGD) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Those with barrett's esophagus
- description
- Those with barrett's esophagus: no dysplasia or low grade dysplasia
- interventionNames
- Procedure: 24 hour pH study and upper endoscopy (EGD)
Primary outcomes (1)
- measure
- activated myofibroblasts
- timeFrame
- 6 months
- description
- The primary end point for the study will be the proportion of patients with activated myofibroblasts (defined as positive staining for SMA and vimentin with negative staining for Desmin, in \> 50% of subepithelial myofibroblasts). This primary end point will be compared between the group with controlled acid reflux and the group without acid reflux.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Prior histological demonstration of Barrett's esophagus that is endoscopically visible; length of visible segment \>/= 1 cm 2. Absence of dysplasia or LGD on biopsies within the past 5 years 3. Ability to provide informed consent 4. Age between 18 years and 90 years at study entry. Exclusion criteria: 1. Eastern Cooperative Oncology Group performance status 3 or 4 2. Inability to tolerate endoscopic procedures 3. Pregnancy: Females of child-bearing age will be screened with pregnancy test. 4. Prior esophageal surgery, or cancer
References
Publications (0)
Data not yet available
No reference posted for this study.