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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.
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 for virtual patient cases when presented with different clinical and prognostic assay information. The data from this study will be published in a peer-review scientific journal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | 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. | |
| Intervention Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational materials on validated methylation assay | Other | Educational materials include overall information on the assay including what the test does, how to use the test and report, and performance metrics on the test. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical performance change in physician behavior. | Change in the overall and the diagnostic and treatment in patient simulations: difference-in-differences regression analysis between the control and the intervention groups' diagnosis and treatment of risk progression in patients with Barrett's esophagus, as measured by the participants' diagnostic and treatment scores. In each category, participants' care recommendations are evaluated, ranging from 0 to a high potential score of up to 10, where higher scores mean increased intensity in surveillance and treatment, to measure the impact of the methylation assay on care decision making. | 1 year |
| The impact of methylation assay on physician confidence in clinical care decision-making. | Measure the confidence in care decisions based on patient's methylation test result: Once the intervention group is exposed to the intervention, education materials on the methylation assay (a validated molecular test for risk stratifying patients with Barrett's esophagus), the scores are measured, on a scale of 0 to 10 from round 1 (pre-exposure) to round 2 (post-exposure) and observe how the assay impacts confidence in the physician following evidence-based patient care. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capsulomics, Inc. | Baltimore | Maryland | 21215 | United States |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| D004066 |
| Digestive System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |