Clinical trial · Interventional
Clinical Utility of Methylation-based Prognostic Assay for Barrett's Esophagus
NCT05846971CI-TRIAL-00066158unknownN/AClinicalTrials.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)
Capsulomics has developed a prognostic assay for patients with diagnosed Barrett's esophagus (BE). This study will measure how gastroenterologists make surveillance and treatment management decisions when presented with different clinical and prognostic assay information.
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 Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Educational materials on validated methylation assay | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control Group
- description
- The control group will receive standard-of-care clinical data for their virtual patient cases. No educational material on the methylation assay will be provided.
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- The intervention group will receive standard-of-care clinical data for their virtual cases along with educational materials about the methylation assay. This group will then be provided with methylation assay data to be used in addition to clinical data.
- interventionNames
- Other: Educational materials on validated methylation assay
Primary outcomes (2)
- measure
- Clinical performance change in physician behavior.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Be currently practicing board-certified gastroenterologist practicing in the United States 2. Have practiced (as a board-certified gastroenterologist) for greater than 2 3. Be English-speaking 4. Have ≥ 50 Barrett's esophagus patients under care annually 5. Have Internet access 6. Have no prior experience with the methylation assay test 7. Provide voluntary informed consent to participate in the study. Exclusion Criteria: 1. Non-practicing gastroenterologists 2. Less than two years of gastroenterology practice 3. Non-English speaking 4. Does not have access to the internet 5. Does not consent to participate in study
References
Publications (0)
Data not yet available
No reference posted for this study.