Clinical trial · Interventional
Rapid Assessment of Esophageal Adenocarcinoma Risk Test
The Acceptability of a Rapid Assessment of Esophageal Adenocarcinoma Risk Test (REACT)
NCT03366012CI-TRIAL-00082401REACTterminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Product recall
Summary
Brief summary (as posted)
This study aims to evaluate the acceptability of a new non-invasive screening device to test for Barrett's esophagus. The investigators will prospectively enroll 100 patients to undergo Cytosponge testing. The time of involvement for an individual will range from 2 weeks to 2 months, depending on the results of the Cytosponge test and time to follow up endoscopy, if indicated.
Conditions
Conditions (2)
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 Esophagus | — | UNRESOLVED | — |
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytosponge | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cytosponge Test
- description
- This arm will include individuals without formal diagnosis of Barrett's esophagus.
- interventionNames
- Device: Cytosponge
Primary outcomes (2)
- measure
- Participation Rate
- timeFrame
- 1 Day
- description
- Participation rate is defined as the percent of patients who agree to undergo Cytosponge testing among number of eligible patients offered Cytosponge testing.
- measure
- Patient Tolerability Determined by Score on Likert Scale
- timeFrame
- 1 Day
- description
- After undergoing the Cytosponge test, subjects will be asked to take a "Cytosponge Post-Procedure Questionnaire" to assess tolerability using a Likert scale from 1 (no discomfort) to 10 (severe discomfort) and whether they would be willing to undergo Cytosponge testing again (yes/no). The scale for each question is rated 1 to 10. Lower scores are "better" (greater tolerability for that particular measure), higher scores are "worse" (less tolerable for that particular measure). Each question on the questionnaire will be assessed independently (i.e. one score per question). No total scores are calculated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Males: Ages 50-75 and at least one of the following: * Gastro-esophageal reflux disease (GERD)\* or * Family history (first degree relative) with Barrett's esophagus or esophageal adenocarcinoma or * Both body mass index (BMI) ≥30 or * A history of cigarette smoking (at least 10 pack years) Females: Ages 50-75 and GERD\* and at least one of the following: * Family history (first degree relative) with Barrett's esophagus or esophageal adenocarcinoma or * BMI ≥30 or * A history of cigarette smoking (at least 10 pack years) Exclusion Criteria: * History of gastric or esophageal cancer * History of esophageal surgery * Known untreated esophageal stricture or uninvestigated dysphagia * Previous upper endoscopy within 10 years * Cancer within 3 years except for non-melanoma skin cancer * Portal hypertension, with or without known varices * Uncontrolled coagulopathy * Uncontrolled major comorbid illness * Inability to tolerate or contraindication to upper endoscopy * Inability to give informed consent GERD defined as either a history of frequent heartburn or fluid regurgitation symptoms (at least weekly for 6 months) or regular use of proton pump inhibitors or histamine-2 receptor antagonists.
References
Publications (0)
Data not yet available
No reference posted for this study.